Drug recall D-0522-2016

Class III Terminated reported Dec 30, 2015

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.

Lots and codes

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.

Recall details

Recalling firm
Oasis Medical, Inc., Glendora, CA
Quantity
15,301 units
Distribution
Nationwide and Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, Belgium
Type
Voluntary: Firm initiated
Recall initiated
October 19, 2015
Terminated
March 14, 2016