Drug recall D-0995-2022
Product
TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
Reason for recall
cGMP deviations: Temperature abuse
Lots and codes
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.
Recall details
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Quantity
- 3 tubes
- Distribution
- USA nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 13, 2022
- Terminated
- November 30, 2023
Related products
- TobraDex – drug information
- NDC 0078-0876 TobraDex · Tobramycin 3 mg/g; Dexamethasone 1 mg/g · Novartis Pharmaceuticals Corporation