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-1526-2012Class IIGANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT)May 25, 2012
D-1496-2012Class IIDEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT)May 25, 2012
D-1515-2012Class IIESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PMay 25, 2012
D-1457-2012Class IIASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 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-1527-2012Class IIG-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)May 25, 2012
D-1492-2012Class IICYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 PRODUCT)May 25, 2012
D-1459-2012Class IIBACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML; BACLOFEN, P.F.May 25, 2012
D-1521-2012Class IIFOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT)May 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-1448-2012Class IIACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT)May 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-1512-2012Class IIEDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVEMay 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-1532-2012Class IIHUMULIN-R INSULIN, 10ML VIAL** 100U/ML INJECTABLE 10 MLS (1 PRODUCT)May 25, 2012
D-1494-2012Class IICYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMANMay 25, 2012
D-1481-2012Class IICEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM INJECTABLE 10 VIMay 25, 2012
D-1476-2012Class IIBUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML (1 PRODUCT)May 25, 2012