FDA-Drug2012-08-22Class II
HYDROXOCOBALAMIN**(VIT B-12) 1000MCG/ML INJECTABLE 30 ML Injectable (4 DIFFERENT PRODUCTS)
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Hazard
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.
Sold states
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Affected count
7 units
Manufactured in
1210 SW 33rd Avenue, Ocala, FL, United States
Products
HYDROXOCOBALAMIN**(VIT B-12) 1000MCG/ML INJECTABLE 30 ML Injectable (4 DIFFERENT PRODUCTS)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1543-2012Don't want to check this manually?
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