Drug 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.
D-0567-2023
Product summary
- Event
- Event 91808
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1568 bottles
- Official record key
drug-enforcement:D-0567-2023
Official wording
Reason: Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Code information: Lot# E220182, Exp. 12/31/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination