Recalls / Class II
Class IID-0995-2022
Product
TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
- Brand name
- Tobradex
- Generic name
- Tobramycin And Dexamethasone
- Active ingredients
- Dexamethasone, Tobramycin
- Route
- Ophthalmic
- NDC
- 0078-0876
- FDA application
- NDA050616
- Affected 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.
Why it was recalled
cGMP deviations: Temperature abuse
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 3 tubes
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2022-04-13
- FDA classified
- 2022-06-09
- Posted by FDA
- 2022-06-15
- Terminated
- 2023-11-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0995-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.