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Recall Observatory FDA recall evidence

Drug product

Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

D-0394-2016

October 19, 2015

Class II

Product summary

Firm
Western Drug
Event
Event 72520
Status
Terminated
Classification
Class II
Quantity
16 containers
Official record key
drug-enforcement:D-0394-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: all lots

Distribution pattern: Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility