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Recall Observatory FDA recall evidence

Drug product

Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3.

D-1347-2014

May 14, 2014

Class III

Product summary

Firm
Oasis Medical Inc
Event
Event 68299
Status
Terminated
Classification
Class III
Quantity
10,549 Bottles
Official record key
drug-enforcement:D-1347-2014

Official wording

Reason: Labeling: Missing Label; The label on the immediate bottle is missing.

Code information: Lot #: OTM-07, Expiry: 12/2015.

Distribution pattern: Nationwide in US

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Missing