Drug 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
D-0522-2016
Product summary
- Event
- Event 72517
- Status
- Terminated
- Classification
- Class III
- Quantity
- 15,301 units
- Official record key
drug-enforcement:D-0522-2016
Official wording
Reason: Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Code information: 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.
Distribution pattern: Nationwide and Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, Belgium
Derived failure modes
-
Potency or specification failure
may not meet specification