# FDA recall D-0099-2018

> **Hetero Labs, Ltd. - Unit III** · Class II · drug recall initiated 2017-10-12.

## Product

Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47

## Reason for recall

Presence of foreign substance (screw)

## Distribution

NJ

## Key facts

- **Recall number:** D-0099-2018
- **Recalling firm:** Hetero Labs, Ltd. - Unit III
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-10-12
- **Report date:** 2017-12-06
- **Termination date:** 2020-09-03

- **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-0099-2018

## Citation

> AI Analytics. FDA recall D-0099-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0099-2018. Source: US FDA. Licensed CC0.

---

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