FDA-Drug2012-08-22Class II
SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 KIT; SERMORELIN ACETATE, LYOPHILIZED 6MG VIAL 2 VIAL; SERMORELIN ACETATE, LYOPHILIZED 9MG KIT 1 KIT 3 KIT 6 KIT; SERMORELIN ACETATE, LYOPHILIZED 9MG VIAL 1 VIAL 2 VIAL 3 VIAL 30 VIAL; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG KIT 1 KIT 3 KIT; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.1
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. 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, West Indies
Affected count
63 units
Manufactured in
1210 SW 33rd Avenue, Ocala, FL, United States
Products
SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 KIT; SERMORELIN ACETATE, LYOPHILIZED 6MG VIAL 2 VIAL; SERMORELIN ACETATE, LYOPHILIZED 9MG KIT 1 KIT 3 KIT 6 KIT; SERMORELIN ACETATE, LYOPHILIZED 9MG VIAL 1 VIAL 2 VIAL 3 VIAL 30 VIAL; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG KIT 1 KIT 3 KIT; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG VIAL 1 VIAL 3 VIAL 4 VIAL 7 VIAL (16 DIFFERENT PRODUCTS)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1616-2012Don't want to check this manually?
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