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Class III: unlikely to cause harmTerminated

Oasis Medical ImproVue Ophthalmic Lubricant Drops Recall

ImproVue Ophthalmic Lubricant Drops (1

Oasis Medical, Inc. · Glendora, CA

Risk level
Class III
Reported by FDA
May 27, 2015
Recall ID
D-1084-2015
Check your lot numberHow we source this data

Summary

Oasis Medical recalled ImproVue Ophthalmic Lubricant Drops starting Apr 10, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1084-2015 on May 27, 2015. Reason: Failed pH specification. Status: Terminated.

Why it was recalled

Failed pH specification

Product description

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

Lot numbers, UPCs & expiration codes

Lot# V0814B, Exp 02/16; V1014H, Exp 04/16

Where it was sold

FL

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-1084-2015
Classification
Class III
Status
Terminated
Recall initiated
Apr 10, 2015
FDA report date
May 27, 2015
Quantity
9,731 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Oasis Medical, Inc.

Original FDA data

Every field from FDA enforcement report D-1084-2015, exactly as published.

Show all FDA fields
City
Glendora
State
CA
Status
Terminated
Country
United States
Event ID
71152
Address
514 S Vermont Ave Bldg 510-528
Code information
Lot# V0814B, Exp 02/16; V1014H, Exp 04/16
Postal code
91741-6205
Report date
May 27, 2015
Product type
Drugs
Recall number
D-1084-2015
Classification
Class III
Recalling firm
Oasis Medical, Inc.
Product quantity
9,731 cartons
Termination date
Dec 18, 2015
Reason for recall
Failed pH specification
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
FL
Recall initiation date
Apr 10, 2015
Initial firm notification
Telephone
Center classification date
May 21, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1084-2015, published May 27, 2015. 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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