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MEDROXYPROGESTERONE ACETATE Recall D-1060-2022

Description: Medroxyprogesterone acetate injectable suspension, 150 mg/mL, 1 mL single dose vial, Rx only, MFG: NorthStarRx/Teva Pharma USA , NDC 16714-981-01

MEDROXYPROGESTERONE ACETATE Recall D-1060-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1060-2022
Event ID89646
BrandMEDROXYPROGESTERONE ACETATE
Generic NameMEDROXYPROGESTERONE ACETATE
ManufacturerMEDROXYPROGESTERONE ACETATE
Original Package?1
Active SubstanceMEDROXYPROGESTERONE ACETATE
Drug RouteINTRAMUSCULAR
DistributionUSA nationwide.
Quantity780 vials
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC16714-981
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 NumberANDA210760
Structured Product Labeling (SPL ID)72bfa421-1b70-4cc4-a366-771028b02cff
Structured Product Labeling (SPL Set ID)7cc31691-8268-4e59-b645-19246931f03c
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