FDA Recall D-0917-2017

Complete Pharmacy and Medical Solutions LLC · Miami Lakes, FL

Class I — life-threatening Ongoing 3789 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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

Lot / code: Lot # 2079ps5, Exp 02/01/2016

Quantity: 1890 syringes

Reason for recall

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

Recall record

Recall number: D-0917-2017
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Distributed throughout Florida
Recall initiated: 2015-12-29
Classified by FDA Center: 2017-06-13
FDA published: 2017-06-21
Recalling firm: Complete Pharmacy and Medical Solutions LLC
Firm location: Miami Lakes, FL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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