The Recall Desk
SevereFDA (Drugs)·D-1454-2012·Announced 2012-08-22

Franck's Compounding Lab Recalls Sterile Amikacin Drugs Due to Contamination

Franck's Compounding Lab is recalling sterile Amikacin drugs because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in injectable drugs, which carries a risk of serious injury or death from infection, fitting the 'Severe' criteria for significant injury risk or Class II with potential for hospitalization.

Plain-English summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The recall involves 42 units of various Amikacin products, including injectable and lyophilized forms, distributed nationwide and to several international locations including the Bahamas, Colombia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies.

The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This lack of assurance of sterility poses a risk of contamination to the patients using these drugs.

Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions. The specific prescription numbers associated with the recalled units are listed in the official recall documentation.

The recalled product

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
Manufacturer
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Category
Drug — Sterile Injectable
Hazard
Affected units
42

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Rx #'s: 0393353
  • 0393353
  • 0407779
  • 0368223
  • 0391077
  • 0395952
  • 0368516
  • 0369866
  • 0389267
  • 0369853
  • 0380629
  • 0371048
  • 0366272
  • 0369842
  • 0369852
  • 0369854
  • 0369862
  • 0369864
  • 0369865
  • 0369868

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 100 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 100 products in this recall →

Related recalls

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Same hazard · microbial contamination

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