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Recall Observatory FDA recall evidence

Drug product

Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014

D-0917-2017

December 29, 2015

Class I

Product summary

Firm
Complete Pharmacy and Medical Solutions LLC
Event
Event 76678
Status
Ongoing
Classification
Class I
Quantity
1890 syringes
Official record key
drug-enforcement:D-0917-2017

Official wording

Reason: Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.

Code information: Lot # 2079ps5, Exp 02/01/2016

Distribution pattern: Distributed throughout Florida

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    presence of mold