Recalls / Class III
Class IIID-1084-2015
Product
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
- Affected lot / code info
- Lot# V0814B, Exp 02/16; V1014H, Exp 04/16
Why it was recalled
Failed pH specification
Recalling firm
- Firm
- Oasis Medical, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 514 S Vermont Ave Bldg 510-528, N/A, Glendora, California 91741-6205
Distribution
- Quantity
- 9,731 cartons
- Distribution pattern
- FL
Timeline
- Recall initiated
- 2015-04-10
- FDA classified
- 2015-05-21
- Posted by FDA
- 2015-05-27
- Terminated
- 2015-12-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1084-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.