Recalls / Class II
Class IID-1496-2022
Product
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
- Affected lot / code info
- Lot#: 9J58A, 9J58B, Exp 8/31/2022
Why it was recalled
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5605 Centerpoint Ct Ste A, N/A, Gurnee, Illinois 60031-5278
Distribution
- Quantity
- 48,636 tubes
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2022-08-31
- FDA classified
- 2022-09-06
- Posted by FDA
- 2022-09-14
- Terminated
- 2024-06-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1496-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.