Pharmedix® is requesting the return of the following product manufactured by WATSON as follows:
Level of Recall |
RETAIL |
Product Name: |
Zovia 1/35E Tablets 28 Day |
Manufacturer: |
Watson |
PMX NDC# |
53002-1591-1, 53002-1591-3, 53002-1591-6 |
PMX LIST# (MNFCT NDC#) |
52544-0383-28 |
Reason for Recall: |
These lots could potentially be contaminated with trace amounts of hydrochlorothiazide (HCTZ). Based on available date, it is unlikely that an adverse event would occur following exposure to the potentially affected product. |
Recalled PMX Lot#’s |
12257-059 |
Recalled Mnfct Lot#’s |
515622A, 515622AA, 515623A, 515623AA, 515623B, 515623BA |
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
Richard J. Mangini, PharmD
Client Services