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Recall Observatory FDA recall evidence

Drug product

Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014

D-0918-2017

April 02, 2016

Class I

Product summary

Firm
Complete Pharmacy and Medical Solutions LLC
Event
Event 76681
Status
Ongoing
Classification
Class I
Quantity
49 vials
Official record key
drug-enforcement:D-0918-2017

Official wording

Reason: Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.

Code information: Lot # 22016, Exp 1/30/2017

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.