# FDA recall D-1213-2018

> **Hetero Labs Limited Unit V** · Class II · drug recall initiated 2018-08-20.

## Product

Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only,  By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.

## Reason for recall

Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1213-2018
- **Recalling firm:** Hetero Labs Limited Unit V
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-20
- **Report date:** 2018-10-03
- **Termination date:** 2021-11-05

- **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-1213-2018

## Citation

> AI Analytics. FDA recall D-1213-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1213-2018. Source: US FDA. Licensed CC0.

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