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METHYLPREDNISOLONE ACETATE Recall D-1061-2022

Description: MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) single dose vial (NDC 6714-088-01) b) 25-count box (NDC16714-088-25), Rx only, MFG: NorthstarRx/Teva Pharma USA

METHYLPREDNISOLONE ACETATE Recall D-1061-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1061-2022
Event ID89646
BrandMETHYLPREDNISOLONE ACETATE
Generic NameMETHYLPREDNISOLONE ACETATE
ManufacturerMETHYLPREDNISOLONE ACETATE
Original Package?1
Active SubstanceMETHYLPREDNISOLONE ACETATE
Drug RouteINTRA-ARTICULAR
DistributionUSA nationwide.
Quantity885 vials
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC16714-088 16714-472
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 Identifier43502P7F0P
Drug Application NumberANDA040557
Structured Product Labeling (SPL ID)dc48f3e4-95ae-40a1-951e-1e46a884443f
Structured Product Labeling (SPL Set ID)40e871a8-98ea-46bd-a593-ab800da186b4
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