Why it was 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Product 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)
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1579-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2012
- FDA report date
- Aug 22, 2012
- Quantity
- 188 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Original FDA data
Every field from FDA enforcement report D-1579-2012, exactly as published.
Show all FDA fields
- City
- Ocala
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62443
- Address
- 1210 SW 33rd Avenue
- Code information
- 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
- Postal code
- 34474-5138
- Report date
- Aug 22, 2012
- Product type
- Drugs
- Recall number
- D-1579-2012
- Classification
- Class II
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Product quantity
- 188 units
- Termination date
- Aug 15, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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)
- Distribution pattern
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
- Recall initiation date
- May 21, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 10, 2012