# FDA recall D-0223-2018

> **Hetero Labs, Ltd. - Unit III** · Class III · drug recall initiated 2017-12-22.

## Product

Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10

## Reason for recall

Presence of foreign substance: metallic razor blade was found in one bottle.

## Distribution

U.S.A. nationwide

## Key facts

- **Recall number:** D-0223-2018
- **Recalling firm:** Hetero Labs, Ltd. - Unit III
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-12-22
- **Report date:** 2018-01-24
- **Termination date:** 2018-03-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hyderabad, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0223-2018

## Citation

> AI Analytics. FDA recall D-0223-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0223-2018. Source: US FDA. Licensed CC0.

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