Oasis Medical, Inc. recalls HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Labe…

Recall date

October 19, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0522-2016

FDA classification

Class III

Brand / firm

Oasis Medical, Inc.

Sold / distributed

Nationwide and Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, Belgium

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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