FDA-Drug2023-05-17Class I
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.
Camber Pharmaceuticals Inc.
Hazard
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Sold states
Nationwide in the USA
Affected count
1568 bottles
Manufactured in
800 Centennial Ave Ste 1, N/A, Piscataway, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0567-2023Don't want to check this manually?
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