# FDA recall D-0228-2018

> **Unichem Pharmaceuticals Usa Inc** · Class II · drug recall initiated 2017-12-19.

## Product

Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01

## Reason for recall

Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.

## Distribution

Product was distributed nationwide in the USA.

## Key facts

- **Recall number:** D-0228-2018
- **Recalling firm:** Unichem Pharmaceuticals Usa Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-12-19
- **Report date:** 2018-01-24
- **Termination date:** 2018-09-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0228-2018

## Citation

> AI Analytics. FDA recall D-0228-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0228-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*