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Recall Observatory FDA recall evidence

Drug product

HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741

D-0523-2016

October 19, 2015

Class III

Product summary

Firm
Oasis Medical, Inc.
Event
Event 72517
Status
Terminated
Classification
Class III
Quantity
3,358 units
Official record key
drug-enforcement:D-0523-2016

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 #: V1014M, Exp 10/2016; V1214B, Exp 12/2016; V0415H, Exp 4/2017.

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