Product Safety Recalls

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METRONIDAZOLE Recall D-1056-2022

Description: Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-1453-61

METRONIDAZOLE Recall D-1056-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1056-2022
Event ID89646
BrandMETRONIDAZOLE
Generic NameMETRONIDAZOLE
ManufacturerMETRONIDAZOLE
Active SubstanceMETRONIDAZOLE
Drug RouteORAL
DistributionUSA nationwide.
Quantity3 boxes/100 blisters per box
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0904-1453
Product NUIN0000175435 M0014907
Pharma Class (EPC)Nitroimidazole Antimicrobial [EPC]
Pharma Class (CS)Nitroimidazoles [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 Identifier140QMO216E
Drug Application NumberANDA070027
Structured Product Labeling (SPL ID)78277efb-75b2-49e1-afc6-cdc452eebe87
Structured Product Labeling (SPL Set ID)efb2f572-1e11-43e3-a653-eaeafc17ec79
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