MEDROXYPROGESTERONE ACETATE Recall D-1143-2022
Description: medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of Italy, NDC 50102-591-40.
MEDROXYPROGESTERONE ACETATE Recall D-1143-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1143-2022 |
| Event ID | 90151 |
| Brand | MEDROXYPROGESTERONE ACETATE |
| Generic Name | MEDROXYPROGESTERONE ACETATE |
| Manufacturer | MEDROXYPROGESTERONE ACETATE |
| Original Package? | 1 |
| Active Substance | MEDROXYPROGESTERONE ACETATE |
| Drug Route | INTRAMUSCULAR |
| Distribution | USA Nationwide |
| Quantity | 79339 syringes |
| Recall Reason | Lack of assurance of sterility |
| Drug Classification | Class II |
| Drug Code Info | 20220622 |
| Product NDC | 50102-591 |
| Recall Initiation Date | 20220506 |
| Report Date | 20220622 |
| Classification Date | 20220610 |
| Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Unique Ingredient Identifier | C2QI4IOI2G |
| Drug Application Number | ANDA210761 |
| Structured Product Labeling (SPL ID) | 8f640668-f6c0-48cc-92bb-94dff0bfad3c |
| Structured Product Labeling (SPL Set ID) | 908573ce-d494-4f7f-95ae-6edbc4e4c5dc |
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