Product: Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmaceuticals, NDC 69238-1615-3
Reason for recall: cGMP deviations: Temperature abuse
Recall initiated: 20220413
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated