CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML ...
FDA Drug Recall #D-1482-2012 — Class II — May 25, 2012
Recall Summary
| Recall Number | D-1482-2012 |
| 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 | 197 units |
Product Description
CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML CEFTAZIDIME, LYOPHILIZED, OPHTHALMIC KIT 2.25% KIT 1 KIT 12 KIT 16 KIT 2 KIT 2 KITS 20 KIT 3 KIT 3 KITS 4 KIT 4 KITS 4 VIALS 5 KIT 6 KIT 6 VIAL 8 KIT CEFTAZIDIME, SDPF - (0.2ML SYRINGE, 30G, 1/2") 2.25% INJECTABLE 0.2 ML 0.4 ML 0.6 ML 0.8 ML 1.2 ML 1.6 ML (25 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: 0400830 0400830 0403915 0369559 0382655 0355231 0363469 0364194 0364586 0365232 0368229 0368502 0368575 0379338 0379547 0383465 0387854 0389349 0390953 0391076 0392073 0394447 0394682 0394934 0395429 0395951 0396729 0397109 0397667 0404203 0404799 0405703 0406025 0408991 0359179 0359179 0348862 0356877 0360153 0363384 0363885 0364194 0364239 0366032 0366271 0368245 0368882 0376169 0380550 0382237 0384296 0385288 0387375 0387380 0387486 0388896 0389392 0390771 0392073 0394447 0399970 0399989 0403141 0403755 0405329 0365743 0384729 0389303 0396299 0353130 0355933 0356625 0362693 0363384 0363667 0368575 0368882 0371797 0375692 0380344 0383379 0387330 0387486 0388896 0392336 0392543 0395951 0396870 0402552 0409017 0375411 0395390 0358612 0362693 0366271 0371046 0375511 0375514 0375515 0375518 0375519 0375692 0384296 0387483 0392020 0392336 0408625 0376091 0399724 0356877 0405109 0408823 0362693 0371046 0375356 0375503 0375504 0375506 0375507 0375510 0375511 0375514 0375515 0375518 0375519 0392020 0392336 0396870 0398875 0368836 0354413 0398562 0354048 0389058 0389206 0405941 0358048 0387432 0402040 0391715 0391715 0393524 0404316 0391708 0402008 0391708
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.