# FDA recall D-1095-2017

> **Hetero USA Inc** · Class II · drug recall initiated 2017-07-20.

## 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 for recall

Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.

## Distribution

NJ

## Key facts

- **Recall number:** D-1095-2017
- **Recalling firm:** Hetero USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-07-20
- **Report date:** 2017-08-23
- **Termination date:** 2019-02-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Piscataway, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1095-2017

## Citation

> AI Analytics. FDA recall D-1095-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1095-2017. Source: US FDA. Licensed CC0.

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