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Standard Operating Procedure Product Recall

This standard operating procedure outlines the process for handling product recalls at a pharmacy. The pharmacist is responsible for ensuring recalled products are removed from shelves in a timely manner. When notified of a recall by distributors, the pharmacist must verify the batch numbers of products in stock and remove any recalled items. All recall documentation and withdrawal forms are maintained for quality records. The goal is to prevent further sales of recalled products and coordinate their return with suppliers.

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Daniel Yves IV Paez
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4K views2 pages

Standard Operating Procedure Product Recall

This standard operating procedure outlines the process for handling product recalls at a pharmacy. The pharmacist is responsible for ensuring recalled products are removed from shelves in a timely manner. When notified of a recall by distributors, the pharmacist must verify the batch numbers of products in stock and remove any recalled items. All recall documentation and withdrawal forms are maintained for quality records. The goal is to prevent further sales of recalled products and coordinate their return with suppliers.

Uploaded by

Daniel Yves IV Paez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
  • Objective: This section details the main purpose of the product recall procedure, focusing on ensuring appropriate action when a product recall is necessary.
  • Responsibility: Outlines the roles of the pharmacist and owner/manager in implementing the product recall process effectively.
  • Procedure: Describes the steps required to conduct a product recall, including communication and withdrawal procedures.
  • Scope: Defines the coverage of the product recall process, specifying that it applies to all products under the DOH-FDA declaration.
  • End of Document: Marks the conclusion of the document, ensuring readers understand the formal end of procedures outlined.
  • Quality of Records: Highlights the importance of maintaining accurate records for further audit and review of the recall process.
  • Forms: Specifies the logbook as the required form for documenting recall actions.

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.

Page 1 of 2
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

Page 2 of 2

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