FDA Drug recall D-1095-2017
Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854
- FDA Drug
- Class II
- terminated
- Published 2017-08-23
On 2017-08-23 the FDA classified a Class II recall of Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 by Hetero Usa, citing failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1095-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-20 |
| Published | 2017-08-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hetero Usa |
| Distribution | NJ |
Product
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
Reason
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Identifiers
| ndc | 31722-833-30 |
|---|---|
| ndc | 31722-833-90 |
| ndc | 31722-833-31 |
| ndc | 31722-833-32 |
| ndc | 31722-834-30 |
| ndc | 31722-834-90 |
| ndc | 31722-834-31 |
| ndc | 31722-834-32 |
| code_info | Lot # ENT17008, Exp 01/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1095-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.