Recalls / Class II
Class IID-125-2013
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.
- Affected lot / code info
- Lot #s: a) 2DV1238, Exp10/13; 2CV0623, 2CV0625, Exp 11/13; b) 2DV1239, Exp 10/13; 2CV0627, Exp 11/13
Why it was recalled
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
- Firm
- L. Perrigo Co.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, N/A, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 86,616 Tablets
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-12-17
- FDA classified
- 2013-01-14
- Posted by FDA
- 2013-01-23
- Terminated
- 2014-01-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-125-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.