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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1143-2022
Event ID90151
BrandMEDROXYPROGESTERONE ACETATE
Generic NameMEDROXYPROGESTERONE ACETATE
ManufacturerMEDROXYPROGESTERONE ACETATE
Original Package?1
Active SubstanceMEDROXYPROGESTERONE ACETATE
Drug RouteINTRAMUSCULAR
DistributionUSA Nationwide
Quantity79339 syringes
Recall ReasonLack of assurance of sterility
Drug ClassificationClass II
Drug Code Info20220622
Product NDC50102-591
Recall Initiation Date20220506
Report Date20220622
Classification Date20220610
Address2 Independence Way
Princeton, NJ 08540-6620
United States
Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
Unique Ingredient IdentifierC2QI4IOI2G
Drug Application NumberANDA210761
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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