Recalls / Class III

Class IIID-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

Affected lot / code info

Lot #: V0814H, V0814J, Exp 08/2016; V1014L, Exp 11/2016; V1114A, Exp 11/2016; V0115G, V0115H, Exp 01/2017; V0215A, V0215B, Exp 02/2017; V0315G, V0315H, V0315O, Exp 03/2017; V0515C, V0515D, 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

15,301 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-0522-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.