Recall: D-1114-2022

Class II - Potentially Harmful

Class IIClassification

2022-04-13Initiated

TerminatedStatus

Mckesson Medical-Surgical Inc.Firm

Product

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

Reason

cGMP deviations: Temperature abuse

Distribution

USA nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.