Pharmedix® is requesting the return of the following product manufactured by Westward as follows:
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Level of Recall: |
RETAIL |
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Product Name: |
Belladonna Alkaloids + PB Tablets |
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Manufacturer: |
Westward Pharmaceuticals |
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PMX NDC# |
53002-361-10, 53002-361-20, 53002-361-30 |
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PMX LIST# (MNFCT NDC#) |
0143-1140-10 |
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Reason for Recall: |
Recalled due to a recently received compliant for black specks on tablets. An analysis and health hazard assessment was conducted on the affected tablets concluding that risk to safety or efficacy of the product is unlikely, due to the minute size of the specks. |
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Recalled PMX Lot #’s |
10312-005, 10341-009, 11091-022, 11117-004, 11199-005, 11256-011, 11264-019, 11272-029, 12088-060 |
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Recalled Mnfct Lot#’s |
67330B, 67328A, 68064B, 68065B, 68666B, 68667A, 69721A |
This voluntary recall is extended to the RETAIL level and is being made with the knowledge of the Food and Drug Administration (FDA). This recall is only to your CLINIC LEVEL. You DO NOT need to contact any clients to whom the product was dispensed.
Our records show that product with the referenced Lot #s has been shipped to your clinic. Please examine your inventory to verify if you have product from these lots remaining in stock. If so, please discontinue dispensing it, quarantine the product, and promptly call Pharmedix® at 1-800-486-1811, Ext. 12 to obtain the approved paperwork to return all recalled product to us for credit to your account.
Please complete the last column in the box below. If you do not have any recalled product left, put a zero. Then sign where indicated and fax this form back to Pharmedix® at 1-800-783-2038 even if you do not have any product from the indicated Lot #(s) remaining in stock.
Sincerely,
Richard J. Mangini, PharmD
Client Services