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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Product description
HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS, 12.5 ML, 120 MLS, 15 MLS, 16 ML, 16 MLS, 2 MLS, 20 ML, 20 MLS, 24 MLS, 25 ML, 30 ML, 30 MLS, 36 MLS, 4 MLS, 40 MLS, 44 ML, 5 MLS, 50 ML, 50 MLS, 6 ML, 6 MLS, 60 MLS, 8 MLS, 80 MLS, 9 ML; HYALURONIDASE - PRESERVATIVE FREE 200 U/ML INJECTABLE 2 MLS; HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML, 630 ML; HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML; HYALURONIDASE 150 U/ML INJECTABLE 0.2 MLS, 0.3 MLS, 0.8 MLS, 1 MLS, 10 MLS, 12 MLS, 15 MLS, 20 MLS, 25 MLS, 3 ML, 4 ML, 40 MLS, 5 MLS, 50 MLS, 60 MLS, 8 MLS, 80 MLS; HYALURONIDASE NO PRES 100 U/ML INJECTABLE 24 MLS, 40 MLS (48 DIFFERENT PRODUCTS)
Lot numbers, UPCs & expiration codes
Rx #'s: 0366959 0388654 0388657 0388658 0388660 0388661 0388662 0388664 0388665 0388667 0388669 0388670 0388672 0388673 0390311 0390330 0390334 0390337 0390340 0390343 0390346 0390348 0390355 0390357 0390359 0390362 0391423 0391429 0391430 0391432 0391438 0391439 0391442 0391448 0391449 0391450 0391453 0391455 0391456 0391458 0391462 0391465 0391467 0391470 0395839 0395841 0395843 0395846 0395850 0395852 0395865 0395867 0395868 0395873 0395874 0395875 0397179 0397189 0397193 0397195 0397203 0397205 0397209 0397210 0397213 0397214 0397216 0397218 0397220 0397223 0397226 0397228 0397229 0399091 0399093 0399097 0399098 0399102 0399140 0399141 0399142 0399147 0399151 0399154 0399843 0399847 0399849 0399850 0399853 0399858 0399859 0399863 0399866 0399870 0399872 0399873 0399877 0399879 0399880 0399881 0402800 0402801 0402802 0402805 0402806 0402808 0402811 0402813 0402815 0402816 0402817 0402818 0402819 0402820 0402821 0402822 0402824 0404680 0404683 0404684 0404686 0404687 0404689 0404690 0404691 0404692 0404693 0404695 0404698 0404701 0404704 0405948 0405949 0405951 0405954 0405955 0405958 0405959 0405963 0405964 0405965 0405967 0405969 0406682 0406685 0406688 0406690 0406691 0406695 0406698 0406702 0406703 0406705 0406709 0406713 0406716 0406719 0406721 0406727 0409290 0409291 0409294 0409297 0409299 0409304 0409305 0409306 0409307 0409308 0409310 0409312 0409313 0409315 0409689 0409691 0409695 0409698 0409699 0409715 0409717 0409718 0409721 0409723 0409729 0409733 0363730 0369336 0382310 0387728 0389871 0394063 0357268 0366414 0398896 0367820 0387644 0370181 0387728 0397783 0367820 0394280 0366959 0397783 0400745 0366414 0387644 0397783 0397783 0369339 0387728 0367820 0382310 0352468 0394551 0406837 0397783 0386976 0398395 0358143 0397783 0372798 0385858 0397783 0367820 0386976 0398032 0385858 0367820 0382402 0395305 0384431 0387955 0397783 0392988
Where it was sold
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and 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-1534-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 25, 2012
- FDA report date
- Aug 22, 2012
- Quantity
- 326 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-1534-2012, exactly as published.
Show all FDA fields
- City
- Ocala
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62416
- Address
- 1210 SW 33rd Avenue
- Code information
- Rx #'s: 0366959 0388654 0388657 0388658 0388660 0388661 0388662 0388664 0388665 0388667 0388669 0388670 0388672 0388673 0390311 0390330 0390334 0390337 0390340 0390343 0390346 0390348 0390355 0390357 0390359 0390362 0391423 0391429 0391430 0391432 0391438 0391439 0391442 0391448 0391449 0391450 0391453 0391455 0391456 0391458 0391462 0391465 0391467 0391470 0395839 0395841 0395843 0395846 0395850 0395852 0395865 0395867 0395868 0395873 0395874 0395875 0397179 0397189 0397193 0397195 0397203 0397205 0397209 0397210 0397213 0397214 0397216 0397218 0397220 0397223 0397226 0397228 0397229 0399091 0399093 0399097 0399098 0399102 0399140 0399141 0399142 0399147 0399151 0399154 0399843 0399847 0399849 0399850 0399853 0399858 0399859 0399863 0399866 0399870 0399872 0399873 0399877 0399879 0399880 0399881 0402800 0402801 0402802 0402805 0402806 0402808 0402811 0402813 0402815 0402816 0402817 0402818 0402819 0402820 0402821 0402822 0402824 0404680 0404683 0404684 0404686 0404687 0404689 0404690 0404691 0404692 0404693 0404695 0404698 0404701 0404704 0405948 0405949 0405951 0405954 0405955 0405958 0405959 0405963 0405964 0405965 0405967 0405969 0406682 0406685 0406688 0406690 0406691 0406695 0406698 0406702 0406703 0406705 0406709 0406713 0406716 0406719 0406721 0406727 0409290 0409291 0409294 0409297 0409299 0409304 0409305 0409306 0409307 0409308 0409310 0409312 0409313 0409315 0409689 0409691 0409695 0409698 0409699 0409715 0409717 0409718 0409721 0409723 0409729 0409733 0363730 0369336 0382310 0387728 0389871 0394063 0357268 0366414 0398896 0367820 0387644 0370181 0387728 0397783 0367820 0394280 0366959 0397783 0400745 0366414 0387644 0397783 0397783 0369339 0387728 0367820 0382310 0352468 0394551 0406837 0397783 0386976 0398395 0358143 0397783 0372798 0385858 0397783 0367820 0386976 0398032 0385858 0367820 0382402 0395305 0384431 0387955 0397783 0392988
- Postal code
- 34474-5138
- Report date
- Aug 22, 2012
- Product type
- Drugs
- Recall number
- D-1534-2012
- Classification
- Class II
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Product quantity
- 326 units
- Termination date
- Aug 13, 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 because 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
- HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS, 12.5 ML, 120 MLS, 15 MLS, 16 ML, 16 MLS, 2 MLS, 20 ML, 20 MLS, 24 MLS, 25 ML, 30 ML, 30 MLS, 36 MLS, 4 MLS, 40 MLS, 44 ML, 5 MLS, 50 ML, 50 MLS, 6 ML, 6 MLS, 60 MLS, 8 MLS, 80 MLS, 9 ML; HYALURONIDASE - PRESERVATIVE FREE 200 U/ML INJECTABLE 2 MLS; HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML, 630 ML; HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML; HYALURONIDASE 150 U/ML INJECTABLE 0.2 MLS, 0.3 MLS, 0.8 MLS, 1 MLS, 10 MLS, 12 MLS, 15 MLS, 20 MLS, 25 MLS, 3 ML, 4 ML, 40 MLS, 5 MLS, 50 MLS, 60 MLS, 8 MLS, 80 MLS; HYALURONIDASE NO PRES 100 U/ML INJECTABLE 24 MLS, 40 MLS (48 DIFFERENT PRODUCTS)
- Distribution pattern
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- Recall initiation date
- May 25, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 10, 2012