Recalls / Class II
Class IID-0124-2017
Product
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
- Affected lot / code info
- Lot: 041306A, Exp 04/19
Why it was recalled
Subpotent Drug: concentration of product is less than labeled amount.
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 29,972 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-10-21
- FDA classified
- 2016-11-02
- Posted by FDA
- 2016-11-09
- Terminated
- 2019-05-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0124-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.