CLASS II Drug recall · Reported 22 Aug 2012 · FDA Enforcement Report
Quadmix 12mg/1mg/10mcg/150mcg/ML Injectable recalled
Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling Quadmix 12mg/1mg/10mcg/150mcg/ML Injectable, distributed nationwide in the US. The recall was initiated on 21 May 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1610-2012
- FDA event ID
- 62443
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab, Ocala, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 May 2012
- FDA classified
- 10 Aug 2012
- Reported
- 22 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 21 May 2012 | Recall initiated by company | |
| 10 Aug 2012 | Classified by FDA | +81 days |
| 22 Aug 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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)
Where it was distributed
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Questions about this recall
Is Quadmix 12mg/1mg/10mcg/150mcg/ML Injectable recalled?
Yes. Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalled Quadmix 12mg/1mg/10mcg/150mcg/ML Injectable on 21 May 2012. The recall is Class II and its status is Terminated. Recall number D-1610-2012.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.