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Recall Observatory FDA recall evidence

Drug product

Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX.

D-1063-2013

August 23, 2013

Class II

Product summary

Firm
Walgreens Co
Event
Event 66330
Status
Terminated
Classification
Class II
Quantity
298 vials
Official record key
drug-enforcement:D-1063-2013

Official wording

Reason: Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.

Code information: Lot #: P50EO07121390A, Exp 1/12/14

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility