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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Detail

Product Description 17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Recall Number D-286-2013
Classification Class II
Code Info ALL Lots
Product Distributed Qty 4 vials (5 mL each)
Reason For Recall Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Event Detail

Event Id 64957
Product Type Drugs
Status Ongoing
Recalling Firm Axium Healthcare Pharmacy dba Balanced Solutions Compounding
City Lake Mary
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-17
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern CO, GA, MI, and Puerto Rico
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