Enforcement Report - Week of September 26, 2012
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Event Detail
| Event ID | 63160 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Sandoz Incorporated |
| City | Broomfield |
| State | CO |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92, | Lot numbers: BJ3338; BJ3339; BJ 3340; BJ3341; BJ3342; BJ6282; BJ7192; BM8498; BJ7202; BJ7203, Exp 12/12 | Class III | Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing. | 43,060 x 90 count bottles | D-1677-2012 |
| Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92 | Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12 | Class III | Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing. | 41,761bottles. | D-1678-2012 |
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