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09-20-2013, 04:41 PM #1
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Recall: TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJ. & TESTOSTERONE AQUEOUS 100 MG/ML
Recall: TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJ, all presentations
Product Detail
Product Description TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Recall Number D-1002-2013
Classification Class II
Code Info 03112013@9, 05242013@17, 05312013@7, 06052013@21
Product Distributed Qty
Reason For Recall Lack of Assurance of Sterility; FDA inspectional findings resulted
in concerns associated with quality control procedures that impacted sterility assurance
Event Detail
Event Id 65876
Product Type Drugs
Status Ongoing
Recalling Firm
Beacon Hill Medical Pharmacy, P.C.
City Southfield
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-26
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern USA nationwide
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