Recalls / Class II
Class IID-0661-2017
Product
LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
- Affected lot / code info
- Lot # LAB15G52, LAB11G52, Exp 6/17; LAB18I52, Exp 8/17; LAB9L52, 11/17; LAB1A62, LAB9A62, Exp 12/17
Why it was recalled
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 107,940 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-03-17
- FDA classified
- 2017-04-11
- Posted by FDA
- 2017-04-19
- Terminated
- 2019-07-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0661-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.