🔍 RecallPedia

MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL 10 VIAL 15 VIAL 2 VIAL 20 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 6 VIAL 7 VIAL 8 VIAL MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) 10,000 UNIT VIAL INJECTABLE 1 KIT 2 KIT 4 KIT MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) II 10,000 UNIT VIAL INJECTA 1 KIT (20 DIFFERENT PRODUCTS)

Class I - Dangerous
💊 Drugs Recalled: May 21, 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: 0406657 0405526 0391965 0393529 0390040 0362442 0370756 0378145 0386548 0393611 0394410 0394751 0394753 0395981 0397434 0398818 0399650 0399825 0399848 0399854 0400112 0401949 0404137 0404138 0404295 0405528 0405700 0407504 0407507 0407770 0408225 0408229 0408670 0410088 0370756 0376063 0391443 0397137 0397222 0397227 0402055 0406817 0391443 0362442 0375777 0390216 0392072 0392079 0392091 0395270 0395277 0395284 0398284 0400112 0403421 0370756 0391443 0362395 0374541 0375777 0395538 0407969 0391443 0374541 0376063 0395987 0395989 0397137 0402055 0387769 0370756 0374541 0376063 0374541 0383057 0385833 0387137 0387361 0387564 0387810 0388478 0390588 0391303 0392314 0392586 0393046 0393339 0394113 0394120 0395617 0395663 0395677 0396139 0397002 0397162 0397275 0397424 0397438 0397462 0397528 0397934 0398287 0398574 0398695 0398774 0399172 0399416 0399658 0399659 0399766 0399862 0400268 0400583 0400688 0400834 0401416 0401429 0401445 0401476 0401499 0401683 0401771 0402350 0403007 0403151 0403488 0403593 0403594 0403874 0404051 0404293 0404566 0404649 0404671 0404837 0404856 0404868 0404916 0405436 0405907 0405938 0406152 0406239 0406886 0407034 0407563 0408732 0381970 0388666 0402009 0376106 0393514 0405150
  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. 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:

MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL 10 VIAL 15 VIAL 2 VIAL 20 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 6 VIAL 7 VIAL 8 VIAL MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) 10,000 UNIT VIAL INJECTABLE 1 KIT 2 KIT 4 KIT MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) II 10,000 UNIT VIAL INJECTA 1 KIT (20 DIFFERENT PRODUCTS)

Product Codes/Lot Numbers:

Rx #'s: 0406657 0405526 0391965 0393529 0390040 0362442 0370756 0378145 0386548 0393611 0394410 0394751 0394753 0395981 0397434 0398818 0399650 0399825 0399848 0399854 0400112 0401949 0404137 0404138 0404295 0405528 0405700 0407504 0407507 0407770 0408225 0408229 0408670 0410088 0370756 0376063 0391443 0397137 0397222 0397227 0402055 0406817 0391443 0362442 0375777 0390216 0392072 0392079 0392091 0395270 0395277 0395284 0398284 0400112 0403421 0370756 0391443 0362395 0374541 0375777 0395538 0407969 0391443 0374541 0376063 0395987 0395989 0397137 0402055 0387769 0370756 0374541 0376063 0374541 0383057 0385833 0387137 0387361 0387564 0387810 0388478 0390588 0391303 0392314 0392586 0393046 0393339 0394113 0394120 0395617 0395663 0395677 0396139 0397002 0397162 0397275 0397424 0397438 0397462 0397528 0397934 0398287 0398574 0398695 0398774 0399172 0399416 0399658 0399659 0399766 0399862 0400268 0400583 0400688 0400834 0401416 0401429 0401445 0401476 0401499 0401683 0401771 0402350 0403007 0403151 0403488 0403593 0403594 0403874 0404051 0404293 0404566 0404649 0404671 0404837 0404856 0404868 0404916 0405436 0405907 0405938 0406152 0406239 0406886 0407034 0407563 0408732 0381970 0388666 0402009 0376106 0393514 0405150

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1579-2012

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Class I - Dangerous

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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.

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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 →