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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 VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML; VITAMIN K (PHYTONADIONE) 5MG/ML INJECTABLE 2 ML; VITAMIN A AQUEOUS EMULSION 50,000 U/ML INJECTABLE 20 ML 40 ML; VITAMIN B COMPLEX (B1,B2,B3,B5,B6) 100/5/100/100/100MG/ML INJECTABLE 120 ML 150 ML 180 ML 90 ML VITAMIN B COMPLEX (B1,B2,B3,B5,B6,B12) INJECTABLE 10 ML 20 ML 40 ML VITAMIN B COMPLEX (B1,B2,B3,B5,B6/ASCORBIC ACID/B12) 12.5/2/12.5/5/5/1MG/1MG/ML 60 ML VITAMIN B COMPLEX -PF (B1,B2,B3,B5,B6) 12.5/12.5/12.5/12.5/12.5MG/ML INJECTABLE 40 ML VITAMIN B COMPLEX PF (B1,B2,B3,B5,B6,B12) INJECTABLE 10 ML VITAMIN B-6/VITAMIN B-12 100MG/1000MCG/ML INJECTABLE 5 ML VITAMIN B-COMPLEX 100*** (30ML) INJECTABLE 30 ML VITAMIN COMPLEX (ASCOR,B1,B2,B3,B5,B6,B12,METH,INOS,CHL,LID) DR. HOLLOWAY INJECT 180 ML 240 ML 30 ML 60 ML VITAMIN D3 IN SESAME OIL 10,000 IU/ML INJECTABLE 60 ML (23 DIFFERENT PRODUCTS)
Recall Number D-1641-2012
Classification Class II
Code Info Rx #'s: 0396112 0396112 0390633 0399923 0392295 0397930 0405691 0357875 0371933 0370806 0371933 0357875 0371933 0373258 0373258 0373258 0391775 0397909 0391540 0371152 0401946 0409588 0391886 0391886 0391886 0391886 0391867 0400517
Product Distributed Qty 38 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Event Detail

Event Id 62443
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 2012-05-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
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