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Monday, October 8, 2012

SOP: Product Recall


I. OBJECTIVE: To provide proper action regarding Product Recall
To establish coordination with the supplier/s when a certain product is recalled.


II. SCOPE: All products that are subjected to be recalled under the DOH-FDA declaration.

III. RESPONSIBILITY

  • Pharmacist
  • Owner/Manager

IV. PROCEDURE

  1. The pharmacist is important person to accomplish this task.
  2. The distributor company will inform the drugstore about the product recall through a Product Recall Letter* containing the details of product/s to be recalled.
  3. The pharmacist must be particular on the batch no or lot no of the product that is being recalled from the market to facilitate removal of stock in the shelves and the store.
  4. After the batch no has been checked, see to it that the product is removed from the shelves so that it will not be sold anymore.
  5. Coordinate to the supplier when will be the product withdrawn.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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