FDAFDA · Food and drugs·Recall number D-1454-2012
AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML; AMIKACIN SULFATE**** 4ML SDV 250MG/ML INJECTABLE 40 ML; AMIKACIN SULFATE, LYOPHILIZED 4MG VIAL INJECTABLE 1 KIT,1 VIAL, 2 KIT, 2 KITS, 2 VIAL, 4 KIT, 4 VIAL; AMIKACIN SULFATE, LYOPHILIZED, OPHTHALMIC KIT 4MG VIAL INJECTABLE 1 KIT, 2 KIT, 4 KITS, 6 KIT; AMIKACIN SULFATE, OPHTHALMIC IN BSS, P.F. 4MG/ML INJECTABLE 0.1 ML, 0.2 ML, 2 ML, 2 MLS (18 DIFFERENT PRODUCTS)
Published August 22, 2012 · Recall initiated: May 25, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Distributor
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- Lot
- Rx #'s: 0393353, 0393353, 0407779, 0368223, 0391077, 0395952, 0368516, 0369866, 0389267, 0369853, 0380629, 0395952, 0371048, 0366272, 0369842, 0369852, 0369854, 0369862, 0369864, 0369865, 0369868, 0369870, 0369874, 0397505, 0404200, 0398563, 0399971, 0400072, 0399080, 0371048, 0383814, 0387475, 0389061, 0399242, 0405935, 0402044, 0387322, 0380230
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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