FDA recall D-0567-2023

Camber Pharmaceuticals Inc. · Class I · 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.

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

Status
Ongoing
Initiation date
2023-03-13
Report date
2023-05-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Piscataway, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0567-2023