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

FDA recall notice · announced April 19, 2017 · Akorn

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.

Notes

Distribution: Nationwide
Lot/code information: Lot # LAB15G52, LAB11G52, Exp 6/17; LAB18I52, Exp 8/17; LAB9L52, 11/17; LAB1A62, LAB9A62, Exp 12/17
Quantity: 107,940 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.