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Recall Observatory FDA recall evidence

Drug product

Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03

D-0078-2018

October 19, 2017

Class III

Product summary

Firm
Allergan Sales, LLC
Event
Event 78325
Status
Terminated
Classification
Class III
Quantity
153,616 bottles
Official record key
drug-enforcement:D-0078-2018

Official wording

Reason: Failed Impurities/Degradation Specifications.

Code information: Lot #: 92575 Exp. JUN-2018

Distribution pattern: Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications