FDA Recall D-0918-2017

Complete Pharmacy and Medical Solutions LLC · Miami Lakes, FL

Class I — life-threatening Ongoing 3694 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

Lot / code: Lot # 22016, Exp 1/30/2017

Quantity: 49 vials

Reason for recall

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

Recall record

Recall number: D-0918-2017
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide and Puerto Rico
Recall initiated: 2016-04-02
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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