🔍 RecallPedia

BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.25MG/ML OPHTHALMIC 2 ML, 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.5MG/ML OPHTHALMIC 1.5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 1% OPHTHALMIC 0.5 ML,1 ML,1.5 ML, 2 ML, 3 ML, 5 ML, 6 ML, 8 ML; BRILLIANT BLUE G, P.F. (STSL) (0.5ML SYRINGE) 0.025% OPHTHALMIC 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (STSL) (0.5ML SYRINGE) 0.15% OPHTHALMIC 2.5 ML; BRILLIANT BLUE G, P.F. 0.25% OPHTHALMIC 1 ML, 10 ML, 20 ML; BRILLIANT BLUE G, P.F. 0.5% OPHTHALMIC 1 ML, 10 ML, 20 ML, 5 ML; BRILLIANT BLUE G, P.F. 1% OPHTHALMIC 10 ML, 12 ML, 15 ML, 2 ML, 2 MLS, 20 ., 20 ML, 30 ML, 4 ML, 40 ML, 50 ML, 6 ML, 80 ML, 9 ML; BRILLIANT BLUE G, P.F. 2% OPHTHALMIC 11 MLS, 15 MLS (43 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: 0387683 0393065 0394633 0385938 0387683 0385222 0394375 0389789 0394526 0391261 0399698 0380189 0387389 0384308 0387389 0390830 0370011 0386507 0394133 0397580 0386507 0393521 0374071 0396478 0360399 0377887 0382420 0360399 0382420 0373839 0373839 0367517 0395929 0396303 0398978 0398980 0398983 0398987 0398061 0395908 0366449 0366449 0385953 0395908 0368413 0386587 0387945 0388529 0388631 0390720 0392250 0393056 0395446 0397146 0397459 0399806 0354531 0397967 0399668 0387481 0394553 0396177 0398687 0395424 0388631 0369860 0381370 0388529 0388631 0390143 0392319 0392455 0381370 0393958 0393960 0395294 0396324 0397146 0397149 0389458 0390143 0357319 0369209 0389845 0396123 0360125 0366749 0366749
  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:

BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.25MG/ML OPHTHALMIC 2 ML, 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.5MG/ML OPHTHALMIC 1.5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 1% OPHTHALMIC 0.5 ML,1 ML,1.5 ML, 2 ML, 3 ML, 5 ML, 6 ML, 8 ML; BRILLIANT BLUE G, P.F. (STSL) (0.5ML SYRINGE) 0.025% OPHTHALMIC 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (STSL) (0.5ML SYRINGE) 0.15% OPHTHALMIC 2.5 ML; BRILLIANT BLUE G, P.F. 0.25% OPHTHALMIC 1 ML, 10 ML, 20 ML; BRILLIANT BLUE G, P.F. 0.5% OPHTHALMIC 1 ML, 10 ML, 20 ML, 5 ML; BRILLIANT BLUE G, P.F. 1% OPHTHALMIC 10 ML, 12 ML, 15 ML, 2 ML, 2 MLS, 20 ., 20 ML, 30 ML, 4 ML, 40 ML, 50 ML, 6 ML, 80 ML, 9 ML; BRILLIANT BLUE G, P.F. 2% OPHTHALMIC 11 MLS, 15 MLS (43 DIFFERENT PRODUCTS)

Product Codes/Lot Numbers:

Rx #'s: 0387683 0393065 0394633 0385938 0387683 0385222 0394375 0389789 0394526 0391261 0399698 0380189 0387389 0384308 0387389 0390830 0370011 0386507 0394133 0397580 0386507 0393521 0374071 0396478 0360399 0377887 0382420 0360399 0382420 0373839 0373839 0367517 0395929 0396303 0398978 0398980 0398983 0398987 0398061 0395908 0366449 0366449 0385953 0395908 0368413 0386587 0387945 0388529 0388631 0390720 0392250 0393056 0395446 0397146 0397459 0399806 0354531 0397967 0399668 0387481 0394553 0396177 0398687 0395424 0388631 0369860 0381370 0388529 0388631 0390143 0392319 0392455 0381370 0393958 0393960 0395294 0396324 0397146 0397149 0389458 0390143 0357319 0369209 0389845 0396123 0360125 0366749 0366749

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1468-2012

Related Recalls

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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 →