Class I
Ongoing
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.
This recall is currently active, issued May 17, 2023. It was issued by Camber Pharmaceuticals Inc..
- Company
- Camber Pharmaceuticals Inc.
- Recall Initiated
- March 13, 2023
- Posted
- May 17, 2023
- Recall Number
- D-0567-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1568 bottles
- Firm Location
- Piscataway, NJ, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot# E220182, Exp. 12/31/2023
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