Home / Recalls / Franck's Lab Inc., D.B.A. Franck's Compounding Lab / D-1452-2012

D-1452-2012 Class II Terminated

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

FDA drug recall D-1452-2012 was initiated by Franck's Lab Inc., D.B.A. Franck's Compounding Lab on May 25, 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 because FDA environmental sampling revealed the presence… The recall status is terminated (terminated Aug 13, 2014). Affected quantity: 529 units.

Recall Details

Product Type: Drugs
Report Date: Aug 22, 2012
Initiation Date: May 25, 2012
Termination Date: Aug 13, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 529 units

Product Description

ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6 ML; ALPROSTADIL 24MCG/ML INJECTABLE 6 ML; ALPROSTADIL 25MCG/ML INJECTABLE 10 ML; ALPROSTADIL 30MCG/ML INJECTABLE 10 ML; ALPROSTADIL 35MCG/ML INJECTABLE 10 ML; ALPROSTADIL 40MCG/ML INJECTABLE 10 ML, 10 ML, 10 VIAL, 15 ML, 2 ML, 20 ML, 3 ML, 30 ML, 40 ML, 5 ML, 50 ML, 6 ML; ALPROSTADIL 50MCG/ML INJECTABLE 10 ML, 2 ML, 20 ML, 5 ML; ALPROSTADIL 60MCG/ML INJECTABLE 20 ML; ALPROSTADIL (M) 500MCG/ML INJECTABLE 10 ML; ALPROSTADIL 100MCG/ML INJECTABLE 5 ML; ALPROSTADIL, STERILE 1,000MCG/ML GEL 10 ML, 12 ML, 20 ML, 3 ML, 30 ML, 6 ML; ALPROSTADIL/PAPAVERINE 10MCG/9MG/ML INJECTABLE; ALPROSTADIL/PHENT 10MCG/0.5MG/ML INJECTABLE 10 ML, 5 ML; ALPROSTADIL/PHENT 17MCG/0.5MG/ML INJECTABLE 10 ML; ALPROSTADIL/PHENTOLAMINE 40MCG/2MG/ML INJECTABLE 10 ML (50 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 because 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, and West Indies

Code Information

Rx #'s: 0358246, 0364805, 0368284, 0378756, 0380820, 0387648, 0388175, 0388294, 0388761, 0391370, 0393218, 0393296, 0394349, 0394946, 0395082, 0395861, 0396187, 0398267, 0401319, 0404291, 0405612, 0388186, 0399034, 0386335, 0400431, 0407531, 0358246, 0378756, 0388743, 0400047, 0404363, 0388082, 0409372, 0348455, 0350663, 0353518, 0355129, 0355693, 0356375, 0357470, 0357616, 0358082, 0358244, 0358434, 0359158, 0363285, 0365259, 0367960, 0369601, 0370844, 0370856, 0371600, 0372364, 0373144, 0373375, 0373510, 0374111, 0374998, 0375459, 0375602, 0376024, 0376332, 0376872, 0377260, 0377875, 0377985, 0379138, 0379565, 0381219, 0383350, 0383828, 0383945, 0385030, 0386074, 0386125, 0386686, 0386742, 0387013, 0387677, 0387846, 0387958, 0388044, 0388436, 0388779, 0388809, 0389393, 0389418, 0389598, 0390069, 0390100, 0390105, 0390505, 0390514, 0390727, 0390999, 0391218, 0391382, 0391595, 0391844, 0391948, 0391988, 0392128, 0392227, 0392536, 0392693, 0392724, 0393539, 0393726, 0393837, 0393890, 0394052, 0394339, 0394442, 0394610, 0394740, 0394779, 0394933, 0395044, 0395610, 0396031, 0396423, 0396428, 0396488, 0396514, 0396850, 0396858, 0396885, 0397148, 0397215, 0397247, 0397393, 0397721, 0397747, 0398357, 0398790, 0398832, 0399045, 0399061, 0399186, 0399368, 0399512, 0399565, 0399867, 0400110, 0400648, 0400692, 0401141, 0401171, 0401436, 0401685, 0401963, 0402524, 0402833, 0402836, 0403131, 0403599, 0403651, 0403776, 0404125, 0404206,0404594,0405337, 0405746, 0406186, 0406350, 0406503, 0406533, 0406608, 0406961, 0407011, 0407522, 0407608, 0408149, 0408243, 0408471, 0408475, 0408733, 0408803, 0408948, 0409227, 0409652, 0408211, 0370597, 0372090, 0372291, 0377260, 0383350, 0384600, 0386742, 0387759, 0394740, 0395554, 0398507, 0399696, 0400665, 0407851, 0384600, 0390561, 0390730, 0391280, 0404039, 0398586, 0387759, 0363140, 0373946, 0379198, 0381414, 0388131, 0390621, 0391087, 0396493, 0402322, 0406179, 0406683, 0407311, 0407850, 0408048, 0392605, 0378371, 0388907, 0391868, 0390192, 0396500, 0352172, 0357035, 0358183, 0358360, 0360788, 0366242, 0366923, 0368523, 0369902, 0374538, 0375333, 0375959, 0377935, 0378040, 0378351, 0379207, 0381237, 0382171, 0385235, 0386937, 0387960, 0388158, 0388210, 0388404, 0388444, 0388445, 0388596, 0388605, 0389108, 0389341, 0389709, 0390347, 0390351, 0390846, 0391197, 0391199, 0391635, 0391700, 0391753, 0392003, 0392022, 0392047, 0392213, 0392423, 0392641, 0392690, 0393922, 0394131, 0394193, 0394388, 0394635, 0394718, 0394798, 0395372, 0395626, 0395876, 0396249, 0396718, 0397811, 0398107, 0398194, 0398343, 0398844, 0398887, 0398982, 0399110, 0399320, 0399528, 0399765, 0400046, 0400096, 0400297, 0400421, 0400424, 0400598, 0400913, 0401400, 0401500, 0401680, 0401934, 0402088, 0402325, 0402328, 0402586, 0402967, 0403274, 0403345, 0403607, 0404401, 0405474,0405498, 0405724, 0406291, 0406457, 0406542, 0407511, 0408231, 0409030, 0409062, 0409526, 0409607, 0409759, 0410307, 0393753, 0397762, 0403540, 0374221, 0382214, 0395621, 0397852, 0402288, 0406445, 0399687, 0374221, 0366701, 0351976, 0354103, 0384453, 0390423, 0391629, 0393615, 0396582, 0397827, 0398720, 0399013, 0403466, 0406583, 0409862, 0397208, 0361392, 0379145, 0380920, 0387005, 0400616, 0404590, 0404931, 0396725, 0392873, 0357803, 0363807, 0365784, 0370228, 0372609, 0376996, 0377620, 0378319, 0380457, 0381999, 0382394, 0382527, 0382743, 0382990, 0386135, 0386929, 0387451, 0387674, 0389081, 0389143, 0389875, 0390000, 0390409, 0391030, 0391711, 0392245, 0392563, 0392705, 0392767, 0393396, 0393794, 0394466, 0395061, 0396510, 0397503, 0397715, 0397737, 0397916, 0397953, 0398923, 0399635, 0399757, 0399812, 0400282, 0400880, 0402467, 0403426, 0403519, 0403728, 0403832, 0404015, 0404522, 0405565, 0405585, 0406128, 0406628, 0407265, 0407357, 0407736, 0407839, 0408178, 0408378, 0409610, 0409944, 0388717, 0394665, 0367237, 0368886, 0401105, 0395886, 0397863, 0388295, 0387427, 0388295, 0397030

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1452-2012
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.

Other recalls by Franck's Lab Inc., D.B.A. Franck's Compounding Lab

D-1468-2012 Class II — BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT… (May 25, 2012)
D-1512-2012 Class II — EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM… (May 25, 2012)
D-1532-2012 Class II — HUMULIN-R INSULIN, 10ML VIAL** 100U/ML INJECTABLE 10 MLS (1 PRODUCT) (May 25, 2012)
D-1516-2012 Class II — ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML… (May 25, 2012)
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)
D-1541-2012 Class II — HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL… (May 25, 2012)
D-1496-2012 Class II — DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT) (May 25, 2012)
D-1478-2012 Class II — BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML… (May 25, 2012)
D-1494-2012 Class II — CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A)… (May 25, 2012)