# FDA recall D-0567-2023

> **Camber Pharmaceuticals Inc.** · Class I · drug recall initiated 2023-03-13.

## Product

Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC# 31722-629-21.

## Reason for recall

Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0567-2023
- **Recalling firm:** Camber Pharmaceuticals Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-03-13
- **Report date:** 2023-05-17

- **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-0567-2023

## Citation

> AI Analytics. FDA recall D-0567-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0567-2023. Source: US FDA. Licensed CC0.

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