D-1114-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2022
- Initiation Date
- April 13, 2022
- Termination Date
- November 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 carton
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
Distribution Pattern
USA nationwide.
Code Information
McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.