Visual Inspection of Parenteral Products

Amit Kumar Mishra

 Visual Inspection Overview
• Visual inspection ranks as an essential operation in parenteral drug production to
ensure the safety of the drug product in its container, such as a vial or syringe.
• The requirement for injections to be “true solutions” appeared in USP IX in
1915.First appearance of “solution clarity”for parenterals occurred in 1936 in NF
IV. Since then, there have been numerous modifications to the compendia in this
regard.
• The industry is seeing an increased emphasis by regulators on having a well-
characterized and robust inspection process, especially with regard to visible
particulates.

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 Objective of the Visual Inspection
• Detect and remove units of drug product with predefined defects in a
reproducible manner in a controlled process .

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 Flaws are typically identified by
visual inspection
• Visual inspection identifies crucial container
integrity defects such as, Cracks, missing or
misapplied stoppers and seals.
• Foreign material such as particulate matter,
precipitation or discoloration of the product,
over- or under-filled containers
• Cosmetic defects such as scratches or dirt on
the outside of the container.
• Specific defects will vary by product and
container type.
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 Patient Risk
Many clinical effects have been
documented in subjects who have
received injections containing
particulate matter contamination.
Examples mentioned below,
• Phlebitis
• Pulmonary emboli
• Pulmonary granulomas
• Immune system dysfunction
• Pulmonary dysfunction
• Infarction
• Death
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 Patient Risk
The patient risk associated with the injection of drugs containing particulate
matter depends on a number of factors,
• Route of administration
• Particle size and shape
• Number of particles injected
• Particle composition
• Patient population

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 Defect Prevention

• No inspection process, manual or automated, can guarantee

complete removal of all visible particulate matter or other
visible defects; thus, prevention of such defects is an important
consideration.
• Good process and product design, along with environmental
control, are necessary to ensure the reliable production of
products with a low particle burden. To ensure the control of
defects throughout the process, manufacturers should consider
an inspection life-cycle approach.

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 Regulatory Requirements (USP)
• All products intended for parenteral administration must be
visually inspected for the presence of particulate matter as
specified in Injections and Implanted Drug Products <1>.
• Dry solids, from which constituted solutions are prepared for
injection, meet the requirements for Completeness and clarity
of solutions in Injections and Implanted Drug Products <1>.
• 100% inspection during the manufacturing process, this
procedure is sufficient to demonstrate that the batch is
essentially free of visible particulates<790>.
• Inspected units must be free of visible particulates when
examined without magnification (except for optical correction
as may be required to establish normal vision) against a black
background and against a white background. <790>. 8
Regulatory Requirements (EU &WHO)
• Filled containers of parenteral products should be inspected
individually for extraneous contamination or other defects.
• When inspection is done visually, it should be done under
suitable and controlled conditions of illumination and
background.
• Operators doing the inspection should pass regular eye-sight
checks, with spectacles if worn, and be allowed frequent
breaks from inspection.
• Where other methods of inspection are used, the process
should be validated and the performance of the equipment
checked at intervals. Results should be recorded.
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Regulatory Requirements (PIC/S) & SCHEDULE M

• All filled containers of parenteral products

should be inspected individually for
extraneous contamination or other defects.

• Filled containers parenteral products shall be

inspected individually for extraneous
contamination or other defects. When
inspection is done visually, it shall be done
under suitably controlled conditions of
illumination and background.
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 Visual Inspection
• 100 % Inspection
• Acceptance Sampling and
Testing
• Remediation and Alternative
Practices
 Reinspection
 Two-Stage Inspection

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Visual Inspection Process Flow

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 100% Visual Inspection
• Each unit of injectable product should be inspected as a part of
manufacturing process.
• Visual inspection should be performed at a point when and where defects
are most easily detected.
 Prior to labelling.
 Insertion into a device or combination product.
• Each unit may be examined manually with the unaided eye,
• Using a conveyor to transport and present the containers to a human
inspector (semi-automated inspection),
• Light obscuration (LO) or electronic image analysis (automated inspection).
• Manual and semi-automated inspection should only be performed by trained
and qualified inspectors
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 100% Visual Inspection
• During 100% inspection, limits on typical rejection rates should be
established to identify atypical lots .
• These limits may be established for categories of defects (e.g., critical,
major, and minor) or for specific types of defects (e.g., particles).
• A review of historical performance is useful in establishing these limits.
• Periodic reassessment of these limits is recommended to account for
expected process improvements and/or normal fluctuations in process
baseline .
• If a limit is exceeded, it should trigger an investigation.

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Acceptance Sampling and Testing
• After 100% inspection, a statistically valid sample is taken from the units
accepted by the inspection process.
• These sampled units should be manually inspected under controlled
conditions by trained inspectors.
• The sample may be a random or a representative sample (e.g., at fixed
time intervals or a fixed number per tray).
• Defects may not be distributed equally over the lot, and therefore a
sampling that represents the whole lot is required.
• Typical sampling plans used for this purpose can be found in the
ANSI/ASQ Z1.4 standard (40). Equivalent plans may also be found in the
ISO 2859 (41) or JIS Z9015 (42) standards.
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 Acceptance Sampling and Testing
• For batch release, the sampling plans listed as
Normal II (ANSI/ASQ Z1.4) are typically
recommended.
• These plans specify a sample size for a range of
batch sizes and specifies selection of an
acceptable quality limit (AQL).
• Typical AQL Values for Visual Inspection Process
 Critical Defects 0.010%-0.10%
 Major Defects 0.10% - 0.65%
 Minor Defects 1.0% - 4.0%

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 Remediation and Alternative Practice
Reinspection
If AQL test results does not meet the pre-defined
acceptance criteria.
• Reinspection should only be conducted using a
procedure that has been approved by the quality
team.
 The number of times reinspection may be
performed (this should be limited and justified)
and approved by the quality team.
 If reinspection is often required, consideration
should be given to improving the sensitivity of
the
 Primary inspection process or
 Manufacturing controls as determined by
root cause analysis. 17
Remediation and Alternative Practice
Two-stage inspection
• In cases where an assignable cause, such as
formation of air bubbles or specific container or
closure variation, results in a high false-
rejection rate (rejection of acceptable units), the
use of a second inspection step may be
considered.
• Such an inspection strategy is more common
with automated inspection systems, where
there is less ability to tolerate normal variation
in product or container.
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Inspection Life-Cycle

Extrinsic, Intrinsic or Inherent Particles

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 Prevention of Particulates
• Robust Design During Development
 Sensitivities of the active
ingredient
 Formulation type
 Final container –closure system
 Product Concentration
 Solution pH
 Critical Micelle Concentration
 Oligomerization
content/Potential
 Package Effects(Large surface
area, product volume, headspace)

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 Prevention of Particulates
• Formulation Components
 The active ingredient may also contribute to
the presence of stability-indicating intrinsic
particles. For example, significant haze and
particles have manifested in aqueous
formulations due to extraction of plasticizers
from filtration media during bulk drug
production .
 Metal content in the active ingredient has
contributed to organometallic salt formation
and has also been observed as precipitated
inorganic salts, blooming long after product
release.
 The active ingredient and related degradation
products may also be relatively insoluble and
may grow to form visible particles. 21
 Prevention of Particulates
• Packaging Components
 Leachables (These substances can also
contribute to the formation of subvisible and
visible particles).
 Formulation attack of the container is a
dramatic change and most often occurs in
glass container systems. Glass containers
undergo corrosion that is 25 times greater at
pH 8 than at pH 4. A formulation pH above 7,
especially with high-ionic strength solutions,
promotes attack of the inner glass surface,
resulting in particle generation. 22
 Particulate Removal by Component
Washing
• Glass Containers and Elastomeric Closures
 Glass-container washing and rinsing process should be evaluated
for particle-reduction capability. The washer validation studies
should demonstrate a reduction in naturally occurring particles or
should use seeded containers to demonstrate such reduction
capability.
 Glass Handling
 Equipment Preparation
 Filling Line

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 Interpretation of Inspection Results
• Defect Classification
 Critical defects are those that may cause
serious adverse reaction or death of the patient, if
the product is used. This classification includes
any nonconformity that compromises the integrity
of the container and thereby risks microbiological
contamination of the sterile product.
 Major defects carry the risk of a temporary
impairment or medically reversible reaction, or
involve a remote probability of a serious adverse
reaction.
 Minor defects do not impact product
performance or compliance; they are often
cosmetic in nature, affecting only product
appearance or pharmaceutical elegance.
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 Unique Product and Container
Consideration
• Lyophilized Product
• Powder Product
• Emulsion and Suspension product
• Amber Containers
• Translucent Plastic Containers
• Large-Volume Containers
• Combination Products

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 Alternate Inspection Strategies for
Supplemental Testing
• Transfer
• Filtration
• Clarification
• Sieving

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Inspection Method and Technologies
• Manual Inspection
• Semi-Automated Visual Inspection
• Automated Visual Inspection

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 Manual Inspection
Light Intensity
• Light levels NLT 2,000–3,750 lux at the
point of inspection for routine inspection
of clear glass containers.
• Special attention should be given to
ensure that inspection is not performed
below the lower limit of 2,000 lux.
• Translucent plastic containers and amber
glass inspection should perform high as
10,000 lux.
• Light intensity in each inspection station
should be measured periodically to
ensure continued compliance within the
specified range.
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 Manual Inspection
Background and Contrast
• The use of both black and white backgrounds is described in USP
<790>, as well as other global pharmacopoeia’s.
• Matte/nonglossy backgrounds are recommended to avoid interference
from reflection.
Inspection Rate
• 10 second per container (5 second each against both black and white
backgrounds).
Container handling and Movement
• Good techniques for manual inspection include a careful swirl or
inversion of the liquid product within the container.

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 Manual Inspection
Inspector Fatigue and Ergonomic
Consideration
• Inspecting for extended periods of time can
cause inspector fatigue and a decrease in
inspection performance.
• FDA expectation-it is recommended that
inspectors be given a break from performing
inspection at least every hour.
• Ideally, the activity of inspection will be limited to
15 to 20 minutes. Afterwards a break for the
eyes should be taken without carrying out any
other activities (ECA Q&A version 2).
• Temperature and humidity should be controlled
for inspector comfort. 30
 Semi Automated Visual Inspection
• Semi-automated visual inspection combines
automated material handling of the containers to
be inspected with human vision and judgment to
make the decision to accept or reject.
• Light intensity must be controlled, as with MVI
• The rate of inspection is controlled by the speed
of the roller/conveyor or some equipment that
allows the inspector to call for a group of
containers each time.
• The background colour is controlled by the
colour of the rollers selected and the colour of
the background seen through the spaces
between the rollers. 31
 Automated Visual Inspection
• Automated visual inspection (AVI)
combines automated material
handling of the containers with
electronic sensing of product
appearance.
• Containers that do not meet pre-
programmed acceptance criteria are
automatically rejected by the machine.
 Light-Obscurtion Method
 Imaging Methods

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QUALIFICATION AND VALIDATION OF
INSPECTION PROCESSES
• Standard
• Preparing and qualifying the
visual inspection defect kits
• Training and Qualification of
Human Inspectors
• Inspector Qualification
Requirements
• Requalification

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 Standard
• Development of inspection standards begins with description of the
defect types that will be represented in the test set(s).
• This information typically comes from the manufacturing area, where
naturally occurring defective units can be identified from rejected
product
• Selection from naturally occurring particulate and physical or cosmetic
production rejects removed from product lots.
• Re-creation of equivalent defect types in a controlled laboratory
environment.
• A single particle per seeded container should be used when determining
detection threshold.
• The use of multiple particles in a container is not recommended in order
to avoid skewing the data by increasing the PoD .
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 Preparing and qualifying the visual
inspection defect kits
• Type of defect kits
• Challenges in
preparing Defect kits
• Batch size of Defect
kits
• What defects should
be included
• Qualification of defect
kits
• Defect kit
maintenance and
expiry 35
 Type of defect kits
 Naturally occurring defects Taken from the actual defects observed in
production
 Represent the actual product and defects
 Expiry is short
 Need frequent inspection to verify its state of qualification
 Types of defects knowledge is based on the defect knowledge of the
site
 Batch to batch variation

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 Challenges in Preparing Defect kits
Intentionally created defects.
 Created defects by an external laboratory or in-house laboratory Not a
true representation of actual rejects. Comparability studies needs to be
performed.
 Creating defects ensures all defect types can be obtained at any point
in time
 Longer Expiry
 Inspection frequency can be relaxed.
 Types of defects knowledge is based on the overall defects in industry
across sites
 UV marking for easy identification of defects from inspected units
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 Defect selection
• Data analysis on deviations, complaints, production rejection trend to
select the defects to be included in the defect library .
• Defect Test for each Unique Configuration
• Scientific Justification & Rationale Required for selection of the defects.
• Factors for Bracketing
 Type of Container
 Size
 Fill Volume
 Typical Defect Type/Size
 Unique Product Characteristics-Emulsion/Suspension/Lyo.

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 Qualification Kit
• Batch size to complete full inspection between two eye rest
• Having 5-20% defect containers mixed with acceptable containers
• Defect distribution
 Critical : 5-7%
 Major : 3-7%
 Minor : 2-6%
 Set-up kit -Having 80% defect containers mixed with acceptable
containers

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 Defect Kit : Particles size
• Lowest particle which can be seen by a unaided eye
• The lowest detectable size for 20/20 human vision under controlled
inspection conditions is generally accepted to be 50 μm.
• Should particle size be ~50µ? • The probability of detection for a single
50 μm particle is ~10%.
• This probability of detection increases to approximately:
 40% for a 100 μm particle
 70% for a 150 um particle
 80-90% for particles 200 μm and larger
• Particle size has to be of a size providing >70% detection probability

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(Particle size)

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 Qualification of defect kits
• Multiple inspections with a detection probability of >70%
• Qualified inspectors to be used for detection
• No. of inspectors should be more to remove operator to operator
variability
• No. of inspections depend upon detection probability
• Higher detection probability, lower multiple inspection
• Lower detection probability, higher multiple inspection
• Generally varies between 10-30 inspection
• Defect categorization should be uniform
• Sufficient inspector pool (person to person variability)
• Acceptable units should not be rejected or should have a probability of
detection less than 30% 42
 Acceptance Criteria

• 100% defect identification by operator during qualification.

• Guidance acceptance criteria
 Detection of 100% of critical defects
 Detection of ≥ 90% of major defects (For particulates)
 Detection of ≥ 80% of minor defects
• Also False Reject acceptance criteria is must. General acceptable value
is LT 5%

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 Defect kit maintenance
• Defect sets are standards by which process is measured, they require
careful maintenance Should be ideally stored in the respective storage
conditions for Naturally occurring defects
• Requalification is required frequently to ensure maintenance of
detection probability
• Expiry to be defined
• Inspections prior to use to ensure the set is in good condition at all
times .
• Replacement and tracking of damaged defects vial during
handling/visual inspection.
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 Training and Qualification of Human Inspectors,
Requalification
• Potential Inspectors should be tested for visual acuity
and colour perception.
• Near –Vision performance should be the equivalent of
20/20.
• Training should be imparted with defect photograph,
or a video library and clear written procedure.
• SME should provide the guidance to potential
inspectors.
• Inspectors fatigue may be addressed in the
qualification process by testing under worst case
condition (e.g. at the end of typical inspection shift)
• Inspector qualification should be performed for each
product type and package that inspector will encounter.
• A bracketing/matrix approach can be used for the
qualification of inspector.
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 Requalification
• Inspectors should be requalified at least annually.
• Requalification includes a test of visual acuity and testing with at least
one product/test set configuration
• Requalification may also be necessary in the event that poor
performance is observed during routine inspection or if the inspector
has been away from the inspection operation for an extended period of
time (e.g., 3 months).
• If an inspector fails the requalification test, a retraining process should
be initiated to identify the root cause and allow the inspector to receive
additional instruction

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 483 Observations
Observation-1
Training
The training of personnel to perform the 100% visual inspection does not include:
a. A provision for recertification.
b. Inspectors for final finished product vials are not provided the training to assure adequate
abilities to detect particulates smaller than one millimeter.
Observation-2
Defect set
a.The type of particles/defects are not always representative of the current manufacturing
process or reflective of complaints received which may be generated from the equipment,
components and materials used in the manufacturing process. Examples of particles in
suspensions.
b. The set of vials used in training includes only vials of clear solutions with particles.

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 483 Observations
Observation-3
Quality oversight over visual inspection is deficient. For example,
•AQL inspections are conducted by personnel that also perform the 100% visual inspection.
•From September 2013 to September 2015, QA oversight over the 100% visual inspection
operations has occurred six times.
Learning
While the visual inspection is typically carried out by manufacturing personnel, the FDA has
stated a clear expectation that the checks on the operation are done by people with no interest in
the performance of the individual inspectors. This observation arose even though the company
made sure that the person who did the AQL sampling on each tray of vials could not be the same
person who had inspected those vials. FDA was looking for a separate independent reporting line
for the people carrying out the checks on the visual inspection operation

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 483 Observations
Observation-4
The preventive maintenance program and the functionality testing program for the Seidenader
semi-automatic visual inspection machines on Line N1 and N2 are deficient. The Seidenader
equipment are used to perform 100% visual inspection of lyophilized vials, including (PRODUCT
NAME) on Line N1. For example,
a.The light intensity of each unit is not verified during routine preventive maintenance and is not
verified prior to use
b.The functionality test used to determine the reject function of the equipment is required before
and after 100% visual inspection. The functionality test results for each equipment are not clearly
documented as to the test results. Only the line clearance results are documented.
c.On DDMMYYYY, an operator on line N2 utilizing equipment #1234 was observed on two
separate occasions pointing to one vial to be rejected, but causing the reject of two vials on both
occasions.

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 483 Observations
Learning
a.The inspectors voiced a clear expectation that the light intensity of the unit would be checked
daily before use, and that the check would be recorded. As a result of this observation, the
company instituted a daily check for light intensity, and included in the 6-monthly replacement of
bulbs that maintenance personnel do a light intensity check on the old bulbs before replacement
as well as on the new bulbs after installation.
b. The functionality of the unit was checked at each line clearance by marking vials and
confirming that they were rejected by the unit. The instruction on this was part of the line
clearance SOP. However, this check was not recorded as a separate line item in the line
clearance record. The success of the check was implied by the completion of the overall line
clearance record. FDA voiced a clear expectation that this check should be a specific line item in
the record.
c.This one was the subject of much discussion! The company was sure that the operator had in
fact marked two vials, and he operator himself verified this, but that the inspector did not see
that. The company did further demonstrations of the system but failed to convince the inspector.
The company restated its position in its response to the observation, but also undertook to
include this as a test in the qualification of future units added to the site. 50
 483 Observations
Observation-5

Qualification of operators for 100% visual inspection and AQL inspection is deficient as
follows:
a. According to SOP-1234567, the test set library shall be largely covered with regards
to existing (i.e. known) defects. No less than eight deviations for cracks on vial bottoms
occurred since approximately DDMMYYYY, for example, deviation DR 6543210 for
(PRODUCT NAME) Lot XXXXX. This defect type has not been added to the test set
library.
b. Doc ABC-123 consists of defect library photos with descriptions and must be read
and understood during training. However, operators are not required to demonstrate
comprehension for qualification. Several of the defects in this document are not in the
physical test set. Examples included (but are not limited to) wrong stopper form
(malformed) and glass splinter visible on bottom of cake..
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 483 Observations
Learning
The management of the defect library is a dynamic process. Some defect samples
change over time, and may become easier or harder to detect. New defects appear
which should be added to the defect library. The FDA inspectors had a clear
expectation that the defect library is subject to regular review, and updated as
appropriate. They also made it clear that the changes to the defect library have to be
done in a controlled way, though they did not express an opinion as to what form of
change control, including approval processes, might be required. The process in place
at the time was that the Subject Matter Expert for the visual inspection process would
add or replace defects as he saw fit. He would also record the changes to the defect
library. However, the process was not defined by SOP, and there was no review or
approval of the changes. There was also no procedural requirement as to the
frequency of review or the timeliness of updating the library. This observation resulted
in a complete overhaul of the management of the defect library. 52
 Warning Letter
Warning Letter-1
• During the inspection, we observed that your procedure for qualifying the operators,
who perform visual inspection is unacceptable because you did not document the
creation of inspectors’ qualification kits.
• The challenge test set vials used to qualify your operators were inadequate because
particle size in the kits is not specified. There is thus no way to determine if the kits
themselves are sufficient to qualify inspectors under the essentially-free standard. 
• Our investigators also documented that your qualification kits for visual inspectors
are created (b)(4) and destroyed after use.

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 Warning Letter
Warning Letter-2
Discarded automated visual inspection machine parameters

In a (b)(4) department office waste bin, our investigators observed discarded forms
used to document and set inspection parameters for your automated visual inspection
machinery. These parameters are used to accept or reject product. In your response,
you noted that you documented and approved final set-up parameters, “but historically
the calculations generated in support of those parameters have not been
preserved.” You indicate that programming the visual inspection machine to detect
defects may not be a CGMP activity. We note that the parameters of this machinery
are used to discriminate between acceptable and unacceptable tablets. Accordingly,
entering reliable settings into machine programming is part of CGMP.

54
 Warning Letter
Warning Letter-3
Your visual inspection program is unreliable. Your qualification and re-qualification of
operators did not include determining the operator’s ability to detect and identify known
product defects for (b)(4) products or products filled in amber vials.

For example, one inspector failed to correctly identify major defects as defined in your
SOP PRD/VAL/003 -05 Qualification of Visual Inspection Operators. Your inspector
incorrectly identified three of (b)(4) vials containing fiber material, one of (b)(4) vials
containing particles, and one of (b)(4) vials that had the incorrect volume from the Kit
(b)(4) challenge set. A second inspector also failed to correctly identify two of (b)(4)
units containing fiber, 2 of (b)(4) units containing particles, and one of (b)(4) units that
had the incorrect fill volume from the (b)(4) Kit (b)(4) challenge set.

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 Warning Letter
Warning Letter-4

A self check of validation batches reported 19 and 6 trays respectively with critical
defects (particles ) during your routine visual inspection evaluation No Investigation
was concluded.
procedure Manual Visual Inspection of …” for visual inspection of product vials states
that the inspection be conducted in minute intervals, with minutes for an eye resting
break. This procedure also states that each individual vial be inspected for seconds
against a black background and seconds against a white background. During the
review of the marketed product the investigator observed that none of the batches met
the elapsed time requirement. reported 19 and 6 trays respectively, with critical defects
(particles) during your routine visual inspection evaluation. No investigation was
conducted.
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 Warning Letter
Warning Letter-5

We have concerns related to your procedures for visual inspection of sterile drug
products and the recurring incidents of particulate matter contamination.

the instructions and acceptance criteria in the previous version of SOP# … “Vials”
firm’s … … firm’s … Acceptable Quality Level (AQL) Sampling of Filled Vials were
inadequate. You firm acceptance criteria for this type of defect permitted units of limited
AQL sample to have visible matter, without rejection ... Lots were released and shipped
to the U.S. using this deficient acceptance criteria for AQL inspection. Based on your
new AQL inspection acceptance criteria, as provided in your firm s response to FDA
483 you would have rejected these lots.

57
 Warning Letter
Warning Letter-6

We have concerns related to your procedures for visual inspection of sterile drug
products and the recurring incidents of particulate matter contamination.
the instructions and acceptance criteria in the previous version of SOP# … “Vials”
firm’s … … firm’s … Acceptable Quality Level (AQL) Sampling of Filled Vials were
inadequate. You firm acceptance criteria for this type of defect permitted units of limited
AQL sample to have visible matter, without rejection ... Lots were released and shipped
to the U.S. using this deficient acceptance criteria for AQL inspection. Based on your
new AQL inspection acceptance criteria, as provided in your firm s response to FDA
483 you would have rejected these lots.

58
 Warning Letter
Warning Letter-7

We have concerns related to your procedures for visual inspection of sterile drug
products and the recurring incidents of particulate matter contamination.
the instructions and acceptance criteria in the previous version of SOP# … “Vials”
firm’s … … firm’s … Acceptable Quality Level (AQL) Sampling of Filled Vials were
inadequate. You firm acceptance criteria for this type of defect permitted units of limited
AQL sample to have visible matter, without rejection ... Lots were released and shipped
to the U.S. using this deficient acceptance criteria for AQL inspection. Based on your
new AQL inspection acceptance criteria, as provided in your firm s response to FDA
483 you would have rejected these lots.

59
 Product Recall 2019
Recall Reason
Date Brand Name(s) Product Description Description
Potential for glass
07/02/2019 Fresenius Kabi, Novaplus Fluorouracil Injection particulate
Mycophenolate Mofetil for
05/03/2019 Par Pharmaceutical injection Foreign Material
Bevacizumab 1.25mg/0.05mL
04/29/2019 AmEx Pharmacy 31G Injectable Product Defect
Levoleucovorin Injection, 250 Presence of particulate
03/18/2019 Mylan mg/25 mL matter
Sodium bicarbonate injection Presence of Particulate
03/15/2019 Hospira USP Matter
Vecuronium Bromide for Potential Foreign
01/08/2019 Sun Pharma Injection Material
01/05/2019 Lupin Pharmaceuticals, Inc. Ceftriaxone for Injection, USP Foreign Material

60
 Product Recall 2018
Promise Prednisolone and Gatifloxacin Due to Small Particulate Floating
10/22/2018 Pharmacy Ophthalmic Solution in the Solution
Due to Presence of Particulates
Piperacillin and Tazobactam for Identified as Glass and Silicone
07/31/2018 Auromedics injection, USP 3.375 g Material
Naloxone Hydrochloride Injection, USP,
0.4 mg/mL, 1 mL in 2.5 mL in the
Carpuject™ Single-use cartridge
06/04/2018 Hospira Syringe System Potential of Foreign Material
05/31/2018 Apotex Fluticasone Propionate Nasal Spray Small Glass Particles
AuroMedics Ampicillin and Sulbactam for Injection
05/14/2018 Pharma LLC USP, 3 grams/ Single-Dose vial Visible Particulate Matter
AuroMedics Piperacillin and Tazobactam for Due to Presence of Glass
05/14/2018 Pharma LLC injection, USP 3.375 g/vial Particulates
Due to The Potential for Empty or
03/05/2018 Hospira, Inc. Hydromorphone HCL Injection, USP Cracked Glass Vials

61
 Product Recall 2018 & 2017
Hospira, Labetalol Hydrochloride Injection, Due to Potential Of Cracked Glass At
02/23/2018 Novaplus USP The Rim Surface Of The Vials
25% Dextrose Injection, USP Due to the Presence of Particulate
02/08/2018 Hospira, Inc. (Infant) Matter
Vancomycin Hydrochloride for Due to the Presence of Particulate
02/08/2018 Hospira, Inc. injection Matter
01/16/2018 Nexterone Amiodarone HCl Presence of Particulate Matter
Due to the Presence of Particulate
01/16/2018 Nexterone Nexterone 150mg/100ml injection Matter
AuroMedics Ampicillin and Sulbactam for
01/10/2018 Pharma LLC Injection USP Presence of Glass Particles in Vial
White particulate matter that has
12/29/2017 AuroMedics Linezolid Injection been identified as mold

AuroMedics Pantoprazole Sodium for Injection

12/29/2017 Pharma LLC 40 mg per vial Contains glass particles

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