Product Safety Recalls

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OFLOXACIN Recall D-1114-2022

Description: Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmaceuticals, NDC 69238-1615-3

OFLOXACIN Recall D-1114-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1114-2022
Event ID89646
BrandOFLOXACIN
Generic NameOFLOXACIN OTIC
ManufacturerOFLOXACIN OTIC
Original Package?1
Active SubstanceOFLOXACIN
Drug RouteAURICULAR (OTIC)
DistributionUSA nationwide.
Quantity1 carton
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC69238-1615 69238-1616
Product NUIN0000175937 M0023650
Drug UPC0369238161533 0369238161663
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 IdentifierA4P49JAZ9H
Drug Application NumberANDA211525
Structured Product Labeling (SPL ID)a12ac48b-c86d-4a98-8515-c3114badff4b
Structured Product Labeling (SPL Set ID)ba37e2a0-1bf7-41ca-bddd-35fcb77f87de
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