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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

Product Description HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE 10 ML, 12 ML, 13 ML, 15 ML, 3 ML, 30 ML, 4 ML, 5 ML, 6 ML, 7 ML, 9 ML (11 DIFFERENT PRODUCTS)
Recall Number D-1544-2012
Classification Class II
Code Info Rx #'s: 0389566 0391189 0400011 0363726 0384953 0389818 0389944 0391513 0394424 0398045 0399810 0400508 0400659 0400899 0402416 0406767 0408616 0408784 0409002 0394645 0404250 0404253 0383078 0390794 0396149 0407773 0380431 0400011 0408013 0385258 0396543 0400011 0386991 0398045
Product Distributed Qty 48 units
Reason For Recall Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Event Detail

Event Id 62416
Product Type Drugs
Status Ongoing
Recalling Firm Franck's Lab Inc., d.b.a. Franck's Compounding Lab
City Ocala
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
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