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Recall Observatory FDA recall evidence

Drug product

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)

D-1452-2012

May 25, 2012

Class II

Product summary

Firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Event
Event 62416
Status
Terminated
Classification
Class II
Quantity
529 units
Official record key
drug-enforcement:D-1452-2012

Official wording

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.

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

Distribution pattern: Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    fungal growth
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility