# FDA recall D-1114-2018

> **Hetero Labs Limited Unit V** · Class II · drug recall initiated 2018-08-08.

## Product

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only   Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854   By: Hetero Hetero Labs Limited Unit V. Polepally  Jadcherla Mahaboob Nagar - 509-301 India.    NDC 31722-746-90  UPC 331722746908

## Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1114-2018
- **Recalling firm:** Hetero Labs Limited Unit V
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2018-08-08
- **Report date:** 2018-08-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jadcherla Mandal, Mahaboob Nagar, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1114-2018

## Citation

> AI Analytics. FDA recall D-1114-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1114-2018. Source: US FDA. Licensed CC0.

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