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Recall Observatory FDA recall evidence

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

March 17, 2017

Class II

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

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility