FDA Drug recall D-1482-2012
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 1…
- FDA Drug
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of 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 1… by Franck S Lab D B A Franck S Compounding Lab, citing 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 re….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1482-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-25 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Franck S Lab D B A Franck S Compounding Lab |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Rx #'s: 0400830 0400830 0403915 0369559 0382655 0355231 0363469 03641…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1482-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.