Product Safety Recalls

Product Recall Tracker

LEVOFLOXACIN Recall D-1088-2022

Description: Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61

LEVOFLOXACIN Recall D-1088-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1088-2022
Event ID89646
Active SubstanceLEVOFLOXACIN
Drug RouteORAL
DistributionUSA nationwide.
Quantity1 box/100 blisters packs per box
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0904-6351 0904-6352 0904-6353
Product NUIN0000175937 M0023650
Pharma Class (EPC)Quinolone Antimicrobial [EPC]
Pharma Class (CS)Quinolones [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 Identifier6GNT3Y5LMF
Drug Application NumberANDA076710
Structured Product Labeling (SPL ID)fd353596-a7b5-4720-83fb-b21c6bb481eb
Structured Product Labeling (SPL Set ID)ac4001ca-882f-4d9b-a570-c1b9d7fd6830
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.