🔍 RecallPedia

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)

Class I - Dangerous
💊 Drugs Recalled: May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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)

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1454-2012

Related Recalls

TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCIN SOLUTION** 0.3% OPHTHALMIC 30 MLS 5 MLS; TOBRAMYCIN SULFATE** (25X2ML) 80MG/2ML INJECTABLE 100 ML 150 ML 50 MLS; TOBRAMYCIN/AMPHOTERICIN-B/BUDESONIDE, STERILE 125MG/5MG/0.6MG/5ML NASO-NEB 70 ML (9 DIFFERENT PRODUCTS)

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

Class I - Dangerous

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.

May 21, 2012 Compounded Drugs Nationwide View Details →

LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 10 ML (1 PRODUCT)

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

Class I - Dangerous

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.

May 21, 2012 Other Drugs Nationwide View Details →

ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6 ML; ALPROSTADIL 24MCG/ML INJECTABLE 6 ML; ALPROSTADIL 25MCG/ML INJECTABLE 10 ML; ALPROSTADIL 30MCG/ML INJECTABLE 10 ML; ALPROSTADIL 35MCG/ML INJECTABLE 10 ML; ALPROSTADIL 40MCG/ML INJECTABLE 10 ML, 10 ML, 10 VIAL, 15 ML, 2 ML, 20 ML, 3 ML, 30 ML, 40 ML, 5 ML, 50 ML, 6 ML; ALPROSTADIL 50MCG/ML INJECTABLE 10 ML, 2 ML, 20 ML, 5 ML; ALPROSTADIL 60MCG/ML INJECTABLE 20 ML; ALPROSTADIL (M) 500MCG/ML INJECTABLE 10 ML; ALPROSTADIL 100MCG/ML INJECTABLE 5 ML; ALPROSTADIL, STERILE 1,000MCG/ML GEL 10 ML, 12 ML, 20 ML, 3 ML, 30 ML, 6 ML; ALPROSTADIL/PAPAVERINE 10MCG/9MG/ML INJECTABLE; ALPROSTADIL/PHENT 10MCG/0.5MG/ML INJECTABLE 10 ML, 5 ML; ALPROSTADIL/PHENT 17MCG/0.5MG/ML INJECTABLE 10 ML; ALPROSTADIL/PHENTOLAMINE 40MCG/2MG/ML INJECTABLE 10 ML (50 DIFFERENT PRODUCTS)

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

Class I - Dangerous

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.

May 25, 2012 Compounded Drugs Nationwide View Details →