HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS, 12.5 ML, 12...
FDA Drug Recall #D-1534-2012 — Class II — May 25, 2012
Recall Summary
| Recall Number | D-1534-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 25, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
| Location | Ocala, FL |
| Product Type | Drugs |
| Quantity | 326 units |
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)
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.
Distribution Pattern
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Lot / 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
Other Recalls from Franck's Lab Inc., d.b.a. Franck's Co...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1513-2012 | Class II | ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PR... | May 25, 2012 |
| D-1452-2012 | Class II | ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, ... | May 25, 2012 |
| D-1514-2012 | Class II | EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJ... | May 25, 2012 |
| D-1451-2012 | Class II | AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16"... | May 25, 2012 |
| D-1492-2012 | Class II | CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%... | May 25, 2012 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.