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Recall Observatory FDA recall evidence

Drug product

Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

D-0309-2015

October 14, 2014

Class II

Product summary

Firm
Vann Healthcare Services Inc
Event
Event 69633
Status
Terminated
Classification
Class II
Quantity
1 vial
Official record key
drug-enforcement:D-0309-2015

Official wording

Reason: Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Code information: Lot #: 071714A

Distribution pattern: KY

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility