Drug 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
D-0661-2017
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 76732
- Status
- Terminated
- Classification
- Class II
- Quantity
- 107,940 bottles
- Official record key
drug-enforcement:D-0661-2017
Official wording
Reason: Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Code information: Lot # LAB15G52, LAB11G52, Exp 6/17; LAB18I52, Exp 8/17; LAB9L52, 11/17; LAB1A62, LAB9A62, Exp 12/17
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility