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Class III: unlikely to cause harmTerminated

Oasis TEARS Recall

Oasis TEARS, Lubricant Eye Drops, 10mL/0

Oasis Medical Inc · Glendora, CA

Risk level
Class III
Reported by FDA
May 28, 2014
Recall ID
D-1347-2014
Check your lot numberHow we source this data

Summary

Oasis Medical recalled Oasis TEARS starting May 14, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1347-2014 on May 28, 2014. Reason: Labeling: Missing Label; The label on the immediate bottle is missing. Status: Terminated.

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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1347-2014, published May 28, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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