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

Recall Number: D-1114-2022

Firm: Mckesson Medical-Surgical Inc. Corporate Office

Classification: Class II

Status: Terminated

Report Date: 20220615

Initiation Date: 20220413

Termination Date: 20231130

Reason for Recall

cGMP deviations: Temperature abuse

Product Description

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