Product Safety Recalls

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METHYLPREDNISOLONE ACETATE Recall D-1097-2022

Description: Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in a) 1 mL single-dose vial (NDC# 0009-3475-01), b) 25-count box (NDC 0009-3475-03), Rx only, MFG: Pfizer

METHYLPREDNISOLONE ACETATE Recall D-1097-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1097-2022
Event ID89646
BrandDEPO-MEDROL
Generic NameMETHYLPREDNISOLONE ACETATE
ManufacturerMETHYLPREDNISOLONE ACETATE
Original Package?1
Active SubstanceMETHYLPREDNISOLONE ACETATE
Drug RouteINTRA-ARTICULAR
DistributionUSA nationwide.
Quantity177 cartons
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0009-3073 0009-3475
Drug UPC0300093073036
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 NumberNDA011757
Structured Product Labeling (SPL ID)b2eabec8-4fae-4441-b4dd-9a01b0f91c4a
Structured Product Labeling (SPL Set ID)9a7b3837-e038-48bf-97e9-78ad463760dc
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