Recalls / Class III
Class IIID-1347-2014
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.
- Affected lot / code info
- Lot #: OTM-07, Expiry: 12/2015.
Why it was recalled
Labeling: Missing Label; The label on the immediate bottle is missing.
Recalling firm
- Firm
- Oasis Medical Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 514 S Vermont Ave Bldg 510-528, N/A, Glendora, California 91741-6205
Distribution
- Quantity
- 10,549 Bottles
- Distribution pattern
- Nationwide in US
Timeline
- Recall initiated
- 2014-05-14
- FDA classified
- 2014-05-22
- Posted by FDA
- 2014-05-28
- Terminated
- 2014-12-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1347-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.