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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