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METHYLPREDNISOLONE ACETATE Recall D-1070-2022

Description: MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0031-01), b) 25-count box (NDC 0703-0031-04), Rx only, MFG: Teva Pharma USA

METHYLPREDNISOLONE ACETATE Recall D-1070-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1070-2022
Event ID89646
BrandMETHYLPREDNISOLONE ACETATE
Generic NameMETHYLPREDNISOLONE ACETATE
ManufacturerMETHYLPREDNISOLONE ACETATE
Original Package?1
Active SubstanceMETHYLPREDNISOLONE ACETATE
Drug RouteINTRA-ARTICULAR
DistributionUSA nationwide.
Quantity983 cartons/1 vial each and 107 cartons/25 vials each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0703-0031 0703-0051
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)322c6b28-132a-41e1-9b0e-ea50f615d24c
Structured Product Labeling (SPL Set ID)978b8416-2e88-4816-8a37-bb20b9af4b1d
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