Home / Recalls / Franck's Lab Inc., D.B.A. Franck's Compounding Lab / D-1610-2012

D-1610-2012 Class II Terminated

Recalled by Franck's Lab Inc., D.B.A. Franck's Compounding Lab — Ocala, FL

FDA drug recall D-1610-2012 was initiated by Franck's Lab Inc., D.B.A. Franck's Compounding Lab on May 21, 2012 and is designated Class II. 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… The recall status is terminated (terminated Aug 15, 2014). Affected quantity: 110 units.

Recall Details

Product Type
Drugs
Report Date
Aug 22, 2012
Initiation Date
May 21, 2012
Termination Date
Aug 15, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
110 units

Product Description

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 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.

Distribution Pattern

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

Code Information

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

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1610-2012
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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  • D-1530-2012 Class II — GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML… (May 25, 2012)
  • D-1453-2012 Class II — ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML… (May 25, 2012)
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  • D-1496-2012 Class II — DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT) (May 25, 2012)
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  • D-1494-2012 Class II — CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A)… (May 25, 2012)

FDA data resources