Camber Pharmaceuticals Inc.: Drug Recall

Recall #D-0567-2023 · 03/13/2023

Class I: Dangerous

Recall Details

Recall Number
D-0567-2023
Classification
Class I
Product Type
Drug
Recalling Firm
Camber Pharmaceuticals Inc.
Status
Ongoing
Date Initiated
03/13/2023
Location
Piscataway, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1568 bottles

Reason for Recall

Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.

Product Description

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.

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.