# FDA recall D-1019-2018

> **Hetero Labs, Ltd. - Unit III** · Class II · drug recall initiated 2018-07-18.

## Product

Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.

## Reason for recall

Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1019-2018
- **Recalling firm:** Hetero Labs, Ltd. - Unit III
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-18
- **Report date:** 2018-08-08
- **Termination date:** 2021-07-15

- **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-1019-2018

## Citation

> AI Analytics. FDA recall D-1019-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1019-2018. Source: US FDA. Licensed CC0.

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