Why it was recalled
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Product description
Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30
Lot numbers, UPCs & expiration codes
Lot # ENT17008, Exp 01/2019
Where it was sold
NJ
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-1095-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 20, 2017
- FDA report date
- Aug 23, 2017
- Quantity
- 5664 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero USA Inc
Original FDA data
Every field from FDA enforcement report D-1095-2017, exactly as published.
Show all FDA fields
- City
- Piscataway
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77846
- Address
- 1035 Centennial Ave
- Code information
- Lot # ENT17008, Exp 01/2019
- Postal code
- 08854-4124
- Report date
- Aug 23, 2017
- Product type
- Drugs
- Recall number
- D-1095-2017
- Classification
- Class II
- Recalling firm
- Hetero USA Inc
- Product quantity
- 5664 bottles
- Termination date
- Feb 27, 2019
- Reason for recall
- Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30
- Distribution pattern
- NJ
- Recall initiation date
- Jul 20, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2017