Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmaceuticals, NDC 69238-1615-3
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Ofloxacin Otic Solution 0.3% in 5 mL bottles due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse. The recalled product was manufactured by Amneal/Akyma Pharmaceuticals and distributed nationwide in the United States. One carton was affected, though McKesson is unable to identify the specific lot number received by individual customers, providing instead the distribution dates and potential shipment dates in recall letters sent to recipients.
The source does not specify a remedy for consumers with this product.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP deviations: Temperature abuse
Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 1 carton Lot/code info: 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.