TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling TobraDex (tobramycin and dexamethasone) ophthalmic ointment, 3.5 gm, a prescription eye medication manufactured by Novartis. The recall affects 3 tubes distributed nationwide across the USA due to manufacturing deviations involving temperature abuse during storage or handling.
Customers who received this product from McKesson between June 1 and September 30, 2021 should check their records to determine if they have any of the recalled ointment in inventory. The recall notification does not specify a remedy for affected 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: 3 tubes 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. The letters clearly explain that consignees should identify product received from MMS between June 1 and September 30, 2021. A consignee should be able to use its own records to determine whether it received an impacted product from MMS during that timeframe and whether it still has any of that product in inventory. The recall notification letter informs consignees that they may contact Sedgwick if they have any questions.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.