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MEDROXYPROGESTERONE ACETATE Recall D-1069-2022

Description: Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials, packaged in a) single dose vial (NDC 0703-6801-01), b) 25-count box single dose vials (NDC 0703-6801-04), Rx only, MFG: Teva Pharma USA

MEDROXYPROGESTERONE ACETATE Recall D-1069-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1069-2022
Event ID89646
BrandMEDROXYPROGESTERONE ACETATE
Generic NameMEDROXYPROGESTERONE ACETATE
ManufacturerMEDROXYPROGESTERONE ACETATE
Original Package?1
Active SubstanceMEDROXYPROGESTERONE ACETATE
Drug RouteINTRAMUSCULAR
DistributionUSA nationwide.
Quantity89 cartons/25 vials per carton and 3 cartons/1 vial
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0703-6801
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierC2QI4IOI2G
Drug Application NumberANDA076553
Structured Product Labeling (SPL ID)fdb50b73-14ad-4e17-8730-8bee0f81a5d0
Structured Product Labeling (SPL Set ID)d279981c-e9e4-4989-bafb-1e184a6d3dd2
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