Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) ...
FDA Recall #D-125-2013 — Class II — December 17, 2012
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.
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
Recalling Firm
L. Perrigo Co. — Allegan, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
86,616 Tablets
Distribution
Nationwide
Code Information
Lot #s: a) 2DV1238, Exp10/13; 2CV0623, 2CV0625, Exp 11/13; b) 2DV1239, Exp 10/13; 2CV0627, Exp 11/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated