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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0567-2023 |
Event ID | 91808 |
Brand | ATOVAQUONE |
Generic Name | ATOVAQUONE |
Manufacturer | ATOVAQUONE |
Original Package? | 1 |
Active Substance | ATOVAQUONE |
Drug Route | ORAL |
Distribution | Nationwide in the USA |
Quantity | 1568 bottles |
Recall Reason | Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product. |
Drug Classification | Class I |
Drug Code Info | 20230517 |
Product NDC | 31722-629 |
Product NUI | N0000175482 N0000175485 |
Pharma Class (EPC) | Antimalarial [EPC] |
Recall Initiation Date | 20230313 |
Report Date | 20230517 |
Classification Date | 20230508 |
Address | 800 Centennial Ave Ste 1 Piscataway, NJ 08854 United States |
Recalling Firm | Camber Pharmaceuticals Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | Y883P1Z2LT |
Drug Application Number | ANDA210692 |
Structured Product Labeling (SPL ID) | 525cd202-a971-44fb-829b-7cabcb0e40e3 |
Structured Product Labeling (SPL Set ID) | 2445304e-4b4e-4358-b098-31f3c49c52ef |
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