PlainRecalls
FDA Drug Low Class III Terminated

HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741

Reported: December 30, 2015 Initiated: October 19, 2015 #D-0524-2016

Product Description

HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741

Reason for Recall

Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Details

Recalling Firm
Oasis Medical, Inc.
Units Affected
14,852 units
Distribution
Nationwide and Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, Belgium
Location
Glendora, CA

Frequently Asked Questions

What product was recalled?
HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741. Recalled by Oasis Medical, Inc.. Units affected: 14,852 units.
Why was this product recalled?
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 30, 2015. Severity: Low. Recall number: D-0524-2016.