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Recall Observatory FDA recall evidence

Drug product

Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.

D-66241-001

September 06, 2013

Class II

Product summary

Firm
Apothecary Shoppe
Event
Event 66241
Status
Terminated
Classification
Class II
Quantity
3540 mL
Official record key
drug-enforcement:D-66241-001

Official wording

Reason: Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory.

Code information: Lot 05022013@20, Exp 10/29/13

Distribution pattern: Oklahoma

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility