PlainRecalls
FDA Drug Moderate Class II Terminated

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)

Reported: August 22, 2012 Initiated: May 25, 2012 #D-1454-2012

Product Description

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)

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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Details

Units Affected
42 units
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Location
Ocala, FL

Frequently Asked Questions

What product was recalled? ▼
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). Recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab. Units affected: 42 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 22, 2012. Severity: Moderate. Recall number: D-1454-2012.

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