Standard Operating Procedure Product Recall

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Document No.

STANDARD OPERATING
PROCEDURE Revision No.

PRODUCT RECALL Page 1 of 2

Revision History
Revised on: Prepared by: Reviewed by: Approved by:

Daniel Yves A. Paez IV, RPh Denice P. Mesias Denice P. Mesias


Pharmacist Owner/Proprietress Owner/Proprietress
Issue No.:
Effective Date:

References
Document No.: Title No.

I. OBJECTIVE:
1. To provide proper action about product recalls.
2. To establish coordination with supplier(s) when a certain product is recalled.

II. SCOPE: All products subjected to product recall under the DOH-FDA declaration.

III. RESPONSIBILITY
 Pharmacist
 Owner/Manager

IV. PROCEDURE
1. The pharmacist is the primary personnel to accomplish this task.
2. Distributor(s) will inform the pharmacy about the product recall through a product recall
letter containing the details of product(s) to be recalled.
3. The pharmacist-in-charge must be particular on the batch number or lot number of the
product being recalled from the market to assist removal of stock in the shelves and the
store.

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4. Upon checking of the batch number, make certain that the product is removed from the
shelves to prevent further sales of the item in question.
5. Coordinate with the supplier when will be the items be withdrawn.
6. Wait for further pronouncement of the recall to be updated.

V. QUALITY OF RECORDS: The letter and withdrawal form should be kept for further
purposes.

VI. FORMS:
 Logbook

VII. END OF DOCUMENT

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