Enforcement Report - Week of January 23, 2013
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Product Detail
| Product Description | Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040. |
|---|---|
| Recall Number | D-125-2013 |
| Classification | Class II |
| Code Info | Lot #s: a) 2DV1238, Exp10/13; 2CV0623, 2CV0625, Exp 11/13; b) 2DV1239, Exp 10/13; 2CV0627, Exp 11/13 |
| Product Distributed Qty | 86,616 Tablets |
| Reason For Recall | Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions |
Event Detail
| Event Id | 63966 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | L. Perrigo Co. |
| City | Allegan |
| State | MI | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-17 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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