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Recall Observatory FDA recall evidence

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

December 17, 2012

Class II

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

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance