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Recall Observatory FDA recall evidence

Drug product

Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

D-0678-2016

January 15, 2016

Class II

Product summary

Firm
Abbott's Compounding Pharmacy, Inc.
Event
Event 73090
Status
Terminated
Classification
Class II
Quantity
5 ml
Official record key
drug-enforcement:D-0678-2016

Official wording

Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.

Code information: All Lots

Distribution pattern: CA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility