Recalls / Class III
Class IIID-0524-2016
Product
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
- Affected lot / code info
- Lot #: V0814C, V0814D, Exp 8/2016; V1014A, V1014B, Exp 10/2016; V1214C, Exp 12/2016; V0115A, V0115B, Exp 01/2017; V0215C, Exp 02/2017; V0315C, V0315D, Exp 03/2017; V0515A, V0515B, Exp 05/2017.
Why it was recalled
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Recalling firm
- Firm
- Oasis Medical, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 514 S. Vermont Ave Bldg 510-528, N/A, Glendora, California 91741-6205
Distribution
- Quantity
- 14,852 units
- Distribution pattern
- Nationwide and Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, Belgium
Timeline
- Recall initiated
- 2015-10-19
- FDA classified
- 2015-12-22
- Posted by FDA
- 2015-12-30
- Terminated
- 2016-03-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0524-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.