Product Safety Recalls

Product Recall Tracker

METRONIDAZOLE Recall D-1048-2022

Description: Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87

METRONIDAZOLE Recall D-1048-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1048-2022
Event ID89646
BrandMETRONIDAZOLE
Generic NameMETRONIDAZOLE
ManufacturerMETRONIDAZOLE
Original Package?1
Active SubstanceMETRONIDAZOLE
Drug RouteVAGINAL
DistributionUSA nationwide.
Quantity7 tubes
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0781-7077
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 NumberANDA077264
Structured Product Labeling (SPL ID)a00b814a-ba5f-4af8-b50d-fa231339148b
Structured Product Labeling (SPL Set ID)0030514f-879d-416d-b422-24b67e334b36
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