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