Recalls / Class II
Class IID-1112-2015
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
- Affected lot / code info
- Lot #: 34019710A, Exp 5/2017
Why it was recalled
Failed Dissolution Specifications: OOS result during stability testing
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, N/A, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 889 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-05-11
- FDA classified
- 2015-06-01
- Posted by FDA
- 2015-06-10
- Terminated
- 2016-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1112-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.