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Recall Observatory FDA recall evidence

Drug product

papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

D-0699-2016

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-0699-2016

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