# FDA recall D-0623-2017

> **Hetero USA Inc** · Class III · drug recall initiated 2017-01-07.

## Product

Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob  Nagar - 509 301, India, NDC 31722-726-30

## Reason for recall

Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-0623-2017
- **Recalling firm:** Hetero USA Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-01-07
- **Report date:** 2017-04-05
- **Termination date:** 2017-08-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Piscataway, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0623-2017

## Citation

> AI Analytics. FDA recall D-0623-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0623-2017. Source: US FDA. Licensed CC0.

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