Recalls / Class II
Class IID-1102-2022
Product
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-36
- Brand name
- Neomycin And Polymyxin B Sulfates And Dexamethasone
- Generic name
- Neomycin And Polymyxin B Sulfates And Dexamethasone
- Active ingredients
- Dexamethasone, Neomycin Sulfate, Polymyxin B Sulfate
- Route
- Ophthalmic
- NDC
- 61314-631
- FDA application
- NDA050065
- 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.
Why it was recalled
cGMP deviations: Temperature abuse
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Manufacturer
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 120 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-1102-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.