FDA recall D-0522-2016

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2015-10-19

Report date

2015-12-30

Termination date

2016-03-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Glendora, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0522-2016