Product Safety Recalls

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IBUPROFEN Recall D-1055-2022

Description: Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61

IBUPROFEN Recall D-1055-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1055-2022
Event ID89646
Active SubstanceIBUPROFEN
Drug RouteORAL
DistributionUSA nationwide.
Quantity1 carton/100 blisters per carton
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0904-5853 0904-5854 0904-5855
Product NUIN0000000160 M0001335 N0000175722
Pharma Class (EPC)Nonsteroidal Anti-inflammatory Drug [EPC]
Pharma Class (CS)Anti-Inflammatory Agents, Non-Steroidal [CS]
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 IdentifierWK2XYI10QM
Drug Application NumberANDA075682
Structured Product Labeling (SPL ID)84f91e64-4b87-4289-b004-150f5b173290
Structured Product Labeling (SPL Set ID)ba86e936-ef72-43e5-aebf-f2c788fe2266
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