Why it was recalled
Failed Dissolution Specifications: OOS result during stability testing
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 34019710A, Exp 5/2017
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1112-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 11, 2015
- FDA report date
- Jun 10, 2015
- Quantity
- 889 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1112-2015, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 71316
- Address
- 425 Privet Rd
- Code information
- Lot #: 34019710A, Exp 5/2017
- Postal code
- 19044-1220
- Report date
- Jun 10, 2015
- Product type
- Drugs
- Recall number
- D-1112-2015
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 889 bottles
- Termination date
- Nov 8, 2016
- Reason for recall
- Failed Dissolution Specifications: OOS result during stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- May 11, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 1, 2015