Product Safety Recalls

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SULFAMETHOXAZOLE Recall D-1059-2022

Description: Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-2725-61

SULFAMETHOXAZOLE Recall D-1059-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1059-2022
Event ID89646
BrandSULFAMETHOXAZOLE AND TRIMETHOPRIM
Generic NameSULFAMETHOXAZOLE AND TRIMETHOPRIM
ManufacturerSULFAMETHOXAZOLE AND TRIMETHOPRIM
Active SubstanceSULFAMETHOXAZOLE TRIMETHOPRIM
Drug RouteORAL
DistributionUSA nationwide.
Quantity32 cartons/100 blister packs per carton
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0904-2725
Product NUIN0000175504 M0020790 N0000185504
Pharma Class (EPC)Sulfonamide Antimicrobial [EPC]
Pharma Class (CS)Sulfonamides [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 IdentifierJE42381TNV AN164J8Y0X
Drug Application NumberANDA076899
Structured Product Labeling (SPL ID)ab6c95db-cd6d-4646-830a-d8474ccb3a2a
Structured Product Labeling (SPL Set ID)abe0d2d5-4879-4b4e-9b57-47ea83a17ba0
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