Drug product
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.
D-125-2013
Product summary
- Firm
- L. Perrigo Co.
- Event
- Event 63966
- Status
- Terminated
- Classification
- Class II
- Quantity
- 86,616 Tablets
- Official record key
drug-enforcement:D-125-2013
Official wording
Reason: 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
Code information: Lot #s: a) 2DV1238, Exp10/13; 2CV0623, 2CV0625, Exp 11/13; b) 2DV1239, Exp 10/13; 2CV0627, Exp 11/13
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance