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Recall Observatory FDA recall evidence

Drug product

ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05

D-1418-2015

August 31, 2015

Class III

Product summary

Firm
Oasis Medical, Inc.
Event
Event 72111
Status
Terminated
Classification
Class III
Quantity
909 cartons
Official record key
drug-enforcement:D-1418-2015

Official wording

Reason: Falied pH specification

Code information: Lot # V0415F, Exp 10/16

Distribution pattern: FL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Falied pH specification