The Recall Desk
SevereFDA (Drugs)·D-125-2013·Announced 2013-01-23

Perrigo Recalls Prednisone Tablets Due to Foreign Substance Contamination

L. Perrigo Co. is recalling specific lots of 10mg Prednisone tablets contaminated with trace food-grade lubricant and stainless steel inclusions.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves physical contamination with stainless steel inclusions, which poses a risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

L. Perrigo Co. is recalling 86,616 tablets of Prednisone, USP, 10mg, Rx Only. The product is distributed nationwide in 48-count and 21-count cartons. The recall is a sub-recall initiated by the manufacturer, West-Ward Pharmaceuticals, due to the presence of foreign substances.

The affected tablets are contaminated with trace amounts of food-grade lubricant and stainless steel inclusions. The specific lots involved are 2DV1238, 2CV0623, 2CV0625, 2DV1239, and 2CV0627, with expiration dates of October 2013 and November 2013.

Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

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.
Manufacturer
L. Perrigo Co.
Affected units
86,616

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Lot #s: a) 2DV1238
  • Exp10/13
  • 2CV0623
  • 2CV0625
  • Exp 11/13
  • b) 2DV1239
  • Exp 10/13
  • 2CV0627

Distribution

Distributed nationwide across the United States.