Drug recall D-0567-2023

Class I Ongoing reported May 17, 2023

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.

Lots and codes

Lot# E220182, Exp. 12/31/2023

Recall details

Recalling firm
Camber Pharmaceuticals Inc., Piscataway, NJ
Quantity
1568 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
March 13, 2023

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