Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51

FDA recall notice · announced June 10, 2015 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01

Reason for recall

Failed Dissolution Specifications: OOS result during stability testing

Notes

Distribution: Nationwide
Lot/code information: Lot #: 34019710A, Exp 5/2017
Quantity: 889 bottles
Status: Terminated
Products in this recall event:
- Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr P (D-1112-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.