Recalls / Class II

Class IID-1454-2012

Product

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)

Affected lot / code info

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

Why it was recalled

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.

Recalling firm

Firm

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1210 SW 33rd Avenue, Ocala, Florida 34474-5138

Distribution

Quantity

42 units

Distribution pattern

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

Timeline

Recall initiated

2012-05-25

FDA classified

2012-08-10

Posted by FDA

2012-08-22

Terminated

2014-08-13

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1454-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.