Policies & Procedures Manual Document Title:

Originating Entity :MEDICATION Medication Recall System

MANAGEMENT AND USE COMMITTEE

Page 1 of 2 Document No.:

Date Originated: Date Revised: Rev. No.:
Approved By: Next Revision Date :

I. Purpose:

I.1-TO Ensure That Defective Drug Products Are Removed From Pharmacy
Stock , Recalled From Patient .
I.2-To Protect Patients From Defective , Sub-Standard Drug Products.

II. Policy:

II.1: As Soon As A drug Recalled Notice Is Received ,The Affected Lot

Is Immediately Withdrawn from all storage areas to ensure that
.drugs is not issued , Dispensed For Use
II.2: The medical staff is notified through the medication management And use
Committee regarding the drug recall.
II.3: The recalled lot is returned to the manufacturer or government agency .the
quantity of the recall drug is indicated on the original notice and kept on
filet the pharmacy for future reference.

III. Responsibilities:
III.1: The medication management and use committee is responsible for notifying
the medical staff regarding the drug recall it is the responsibility of pharmacy
department and 48 M. H staff to implement this approved policy and
procedure.

IV. Definitions:

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 IV.1: Drug recall means the process by which a medication is declared
contaminated, mislabeled or dangerous by a manufacturer or national
international drug control body , is withdrawn from various storage and
dispensing areas in 48 M.H .

Note:- drugs recall from a patient because of wrong dispensing are not covered
in this policy.

IV. 2 : Defects in medications include ,but are not limited to ,the following :
IV.2.1: Inadequate or faulty packaging.
IV.2.2: Inadequate or confusing labeling.
IV.2.3: Deteriorated or contaminated drugs.
IV.2.4: Drugs professionally considered to be defective or undesirable .

V. Procedure:

V.1: Check and withdraw affected Lot form all storage and dispensing areas of
The hospital.
V.1.1: The areas inspected shall include the pharmacy store room and all
Pharmacy dispensing areas.
V.1.2: If the drug is on the floor stock list, concerned nursing stations are to
be checked by designated pharmacy staff.
V.1.3: designated pharmacy stuff will determine if any in-patient is currently
receiving the recall medication, check the individual unit dose bin
and refrigerator on the nursing station of the area where it has been
determined that a patient is receiving the recalled medication.

V.2: Determine the intensity of the recall and if deemed necessary, convene an
urgent meeting of the Medication Management of use Committee.
Recalled lot will be classified according to F. D. A. criteria as
follows :

V.2.1: When the use of or exposure to a violated health product may cause
permanent or irreversible adverse health consequences.

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V.2.2: When the use of or exposure to a violated health product may cause
temporary or medically reversible adverse health consequences or where
the probability of serious adverse consequence is remote.
V.2.3: When the use of or exposure to a violated health product is not likely to
cause adverse health consequence.
V.2.3.1: Informs all pharmacy, medical and nursing staff as deemed necessary
by the medication management and use committee.

V.3: Isolate all affected quantity of the recalled drug in a secured area for
processing as per instructions which should be explicitly contained in the
department.
V.3.1: The pharmacy store room is the designated area for storing all recalled
medication (quarantine).
V.3.2: All recalled drug must be labelled recalled to insure that they will not be
in advertently used.

V.4: Issue recalled quantity in the computer to “return to warehouse “option.

V.4.1: The record should contain the generic and trade name, the company and
lot number, the manufacturing and expiration dates of the drug, if
available.
V.4.2: The supervisor or his or her designee performing the check should sign
and indicate date on the form.
V.5: Copies of notification and form to administration and all users or
suspected users of the re recalled drug .
V.6: Purchasing will contact the representative and obtain credit or
acceptable replacement as soon as possible.

VI. Documentation Requirements:

VI.1: Drug recall form.

VII. References:
VII.1: JCI standards .

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 Drug Recall Form.

1- Date of Recall Notice Received :

2- Recall by:
* Manufacturer * other entity.
3- Medication description.
Generic name.
Brand name
Manufacturer date:
Lot No :
Manufacturing Date
Expiration date.
4- Quantity available.
5- All storage and dispensing areas checked by :
Date.
Name .
Signature .