Product Safety Recalls

Product Recall Tracker

ATOVAQUONE Recall D-0567-2023

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.

ATOVAQUONE Recall D-0567-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0567-2023
Event ID91808
Original Package?1
Active SubstanceATOVAQUONE
Drug RouteORAL
DistributionNationwide in the USA
Quantity1568 bottles
Recall ReasonMicrobial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Drug ClassificationClass I
Drug Code Info20230517
Product NDC31722-629
Product NUIN0000175482 N0000175485
Pharma Class (EPC)Antimalarial [EPC]
Recall Initiation Date20230313
Report Date20230517
Classification Date20230508
Address800 Centennial Ave Ste 1
Piscataway, NJ 08854
United States
Recalling FirmCamber Pharmaceuticals Inc.
Initial Notification Letter
Unique Ingredient IdentifierY883P1Z2LT
Drug Application NumberANDA210692
Structured Product Labeling (SPL ID)525cd202-a971-44fb-829b-7cabcb0e40e3
Structured Product Labeling (SPL Set ID)2445304e-4b4e-4358-b098-31f3c49c52ef
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.