Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL), Rx only, Mfd for: Alcon Surgical Inc., NDC 0065-0411-30
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Betadine 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution), a prescription eye preparation solution sold in 1 fluid ounce bottles. The recall affects 799 cartons distributed nationwide in the United States. The product is being recalled due to manufacturing deviations involving temperature abuse during storage or handling.
McKesson Medical-Surgical has indicated it cannot identify the specific lot numbers received by individual customers, but has provided distribution dates to affected consignees so they can determine if their product may have been impacted based on the shipment timeframes. The source does not specify a remedy or next steps for consumers.
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: 799 cartons/1 bottle each 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.