# FDA recall D-0594-2018

> **Hetero Labs, Ltd. - Unit III** · Class II · drug recall initiated 2018-01-10.

## Product

Aripiprazole Tablets, USP, 10 mg, 30-count bottles,  Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30

## Reason for recall

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

## Distribution

NJ Only

## Key facts

- **Recall number:** D-0594-2018
- **Recalling firm:** Hetero Labs, Ltd. - Unit III
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-10
- **Report date:** 2018-02-14
- **Termination date:** 2020-09-21

- **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-0594-2018

## Citation

> AI Analytics. FDA recall D-0594-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0594-2018. Source: US FDA. Licensed CC0.

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