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METHYLPREDNISOLONE ACETATE Recall D-1072-2022

Description: MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL multi-dose vial, Rx only, MFG: Teva Pharma USA, NDC 0703-0045-01

METHYLPREDNISOLONE ACETATE Recall D-1072-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1072-2022
Event ID89646
BrandMETHYLPREDNISOLONE ACETATE
Generic NameMETHYLPREDNISOLONE ACETATE
ManufacturerMETHYLPREDNISOLONE ACETATE
Original Package?1
Active SubstanceMETHYLPREDNISOLONE ACETATE
Drug RouteINTRALESIONAL
DistributionUSA nationwide.
Quantity796 cartons/1 vial each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0703-0043 0703-0045 0703-0063
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 NumberANDA040620
Structured Product Labeling (SPL ID)57a4e988-2e4a-4615-a3f7-7ef65abd0e16
Structured Product Labeling (SPL Set ID)769cc1ae-bdf4-47e4-9a9f-c6327bd7dbf4
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