Why it was recalled
Labeling: Missing Label; The label on the immediate bottle is missing.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: OTM-07, Expiry: 12/2015.
Where it was sold
Nationwide in US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1347-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 14, 2014
- FDA report date
- May 28, 2014
- Quantity
- 10,549 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Oasis Medical Inc
Original FDA data
Every field from FDA enforcement report D-1347-2014, exactly as published.
Show all FDA fields
- City
- Glendora
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 68299
- Address
- 514 S Vermont Ave Bldg 510-528
- Code information
- Lot #: OTM-07, Expiry: 12/2015.
- Postal code
- 91741-6205
- Report date
- May 28, 2014
- Product type
- Drugs
- Recall number
- D-1347-2014
- Classification
- Class III
- Recalling firm
- Oasis Medical Inc
- Product quantity
- 10,549 Bottles
- Termination date
- Dec 17, 2014
- Reason for recall
- Labeling: Missing Label; The label on the immediate bottle is missing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in US
- Recall initiation date
- May 14, 2014
- Initial firm notification
- Letter
- Center classification date
- May 22, 2014