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Recall Observatory FDA recall evidence

Drug product

HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741

D-0524-2016

October 19, 2015

Class III

Product summary

Firm
Oasis Medical, Inc.
Event
Event 72517
Status
Terminated
Classification
Class III
Quantity
14,852 units
Official record key
drug-enforcement:D-0524-2016

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 #: V0814C, V0814D, Exp 8/2016; V1014A, V1014B, Exp 10/2016; V1214C, Exp 12/2016; V0115A, V0115B, Exp 01/2017; V0215C, Exp 02/2017; V0315C, V0315D, Exp 03/2017; V0515A, V0515B, 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