Franck's Lab Inc., d.b.a. Franck's Compounding Lab

FDA Regulatory Profile

Summary

Total Recalls
198
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1448-2012Class IIACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT)May 25, 2012
D-1489-2012Class IICYCLOPENT/FLURBIPR/PHENYLEPH/PROPARACAINE .25%/0.0075%/0.625%/0.125% OPHTHALMIC 56 ML, 70 ML (2 DIFFMay 25, 2012
D-1512-2012Class IIEDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVEMay 25, 2012
D-1533-2012Class IIHYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID SODIUM SALT, P.F. 20MMay 25, 2012
D-1502-2012Class IIDICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/0.1ML INJECTABLE 0.5 ML, 2 ML, 4 ML (3 DMay 25, 2012
D-1485-2012Class IICISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS)May 25, 2012
D-1543-2012Class IIHYDROXOCOBALAMIN**(VIT B-12) 1000MCG/ML INJECTABLE 30 ML Injectable (4 DIFFERENT PRODUCTS)May 25, 2012
D-1453-2012Class IIALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15May 25, 2012
D-1481-2012Class IICEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM INJECTABLE 10 VIMay 25, 2012
D-1501-2012Class IIDIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML, 20 ML, 300May 25, 2012
D-1530-2012Class IIGLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCMay 25, 2012
D-1496-2012Class IIDEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT)May 25, 2012
D-1541-2012Class IIHYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONMay 25, 2012
D-1521-2012Class IIFOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT)May 25, 2012
D-1504-2012Class IIDMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 ML, 5 ML (4 DIFFEREMay 25, 2012
D-1478-2012Class IIBUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.May 25, 2012
D-1532-2012Class IIHUMULIN-R INSULIN, 10ML VIAL** 100U/ML INJECTABLE 10 MLS (1 PRODUCT)May 25, 2012
D-1468-2012Class IIBRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5ML May 25, 2012
D-1516-2012Class IIETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML, 20 ML, 40 ML, 5 ML, May 25, 2012
D-1527-2012Class IIG-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)May 25, 2012