FDA-Drug2015-12-30Class III
HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
Oasis Medical, Inc.
Hazard
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Sold states
Nationwide and Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, Belgium
Affected count
15,301 units
Manufactured in
514 S. Vermont Ave Bldg 510-528, N/A, Glendora, CA, United States
Products
HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0522-2016Don't want to check this manually?
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