FDA Drug recall D-1454-2012
AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML
- FDA Drug
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML 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-1454-2012 |
| 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
AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML; AMIKACIN SULFATE**** 4ML SDV 250MG/ML INJECTABLE 40 ML; AMIKACIN SULFATE, LYOPHILIZED 4MG VIAL INJECTABLE 1 KIT,1 VIAL, 2 KIT, 2 KITS, 2 VIAL, 4 KIT, 4 VIAL; AMIKACIN SULFATE, LYOPHILIZED, OPHTHALMIC KIT 4MG VIAL INJECTABLE 1 KIT, 2 KIT, 4 KITS, 6 KIT; AMIKACIN SULFATE, OPHTHALMIC IN BSS, P.F. 4MG/ML INJECTABLE 0.1 ML, 0.2 ML, 2 ML, 2 MLS (18 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: 0393353, 0393353, 0407779, 0368223, 0391077, 0395952, 0368516, 0369866, 0389267, 0369853, 0380629, 0…Rx #'s: 0393353, 0393353, 0407779, 0368223, 0391077, 0395952, 0368516, 0369866, 0389267, 0369853, 0380629, 0395952, 0371048, 0366272, 0369842, 0369852, 0369854, 0369862, 0369864, 0369865, 0369868, 0369870, 0369874, 0397505, 0404200, 0398563, 0399971, 0400072, 0399080, 0371048, 0383814, 0387475, 0389061, 0399242, 0405935, 0402044, 0387322, 0380230 |
|---|
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-1454-2012%22
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