FDA Drug recall D-1610-2012
QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML
- FDA Drug
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 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. FDA environmental sampling revealed….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1610-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-21 |
| 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
QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML; QUADMIX 15MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/1MG/10MCG/100MCG/ML INJECTABLE 1 ML 10 ML 2 ML 30 ML 5 ML; QUADMIX 30MG/1MG/20MCG/100MCG/ML INJECTABLE 10 ML 10 MLS 5 ML; QUADMIX 30MG/1MG/40MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/2MG/20MCG/100MCG/ML INJECTABLE 10 ML 2 ML 4 ML; QUADMIX 30MG/2MG/40MCG/100MCG/ML INJECTABLE 10 ML 15 ML; QUADMIX 30MG/2MG/60MCG/100MCG/ML INJECTABLE 5 ML; QUADMIX 30MG/3MG/50MCG/100MCG/ML INJECTABLE 10 ML 2.5 ML; QUADMIX 30MG/4MG/60MCG/100MCG/ML INJECTABLE 5 ML; QUADMIX 30MG/6MG/60MCG/100MCG/ML INJECTABLE 5 ML (22 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. 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: 0398154 0361427 0394539 0398379 0398383 0398654 0401481 0354901 0358554 0362399…Rx #'s: 0398154 0361427 0394539 0398379 0398383 0398654 0401481 0354901 0358554 0362399 0364565 0365677 0374214 0378140 0387717 0387828 0388410 0388613 0389582 0389605 0389831 0389995 0391836 0392132 0392791 0395761 0395780 0398565 0399139 0399236 0402039 0402348 0402913 0404655 0404956 0407300 0407826 0407886 0409193 0409392 0381541 0381541 0374200 0388333 0389328 0389995 0400261 0400734 0401275 0408300 0369037 0399507 0393432 0400721 0376498 0398517 0405296 0382422 0383030 0387924 0388078 0389173 0389292 0389398 0392540 0396157 0396195 0396743 0401143 0408802 0362184 0403309 0362184 0358883 0388846 0392210 0399742 0397435 0378334 0380750 0370502 0404839 0355136 0375023 0406832 |
|---|
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-1610-2012%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.