PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1114-2022

Product Description

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

Details

Units Affected
1 carton
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmaceuticals, NDC 69238-1615-3. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 1 carton.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1114-2022.