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Recall Observatory FDA recall evidence

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

October 19, 2015

Class III

Product summary

Firm
Oasis Medical, Inc.
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

    reason.potency_specification_failure · v1.0.0

    may not meet specification