Downing Labs, LLC

FDA Regulatory Profile

Summary

Total Recalls
48
510(k) Clearances
0
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0367-2016Class IIMagnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwenOctober 16, 2015
D-0358-2016Class IITNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244October 16, 2015
D-0369-2016Class IIDMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 7542October 16, 2015
D-0382-2016Class IIThiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, DaOctober 16, 2015
D-0338-2016Class IIL-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, DalOctober 16, 2015
D-0371-2016Class IIFolic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, DallOctober 16, 2015
D-0355-2016Class IIHCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,October 16, 2015
D-0377-2016Class IIZinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, October 16, 2015
D-0357-2016Class IIEDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, SuOctober 16, 2015
D-0341-2016Class IIAcetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL vial, Rx onOctober 16, 2015
D-0352-2016Class IIGlucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 11October 16, 2015
D-0342-2016Class IIAscorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only,October 16, 2015
D-0375-2016Class IIDexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, DOctober 16, 2015
D-0364-2016Class IISermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,October 16, 2015
D-0359-2016Class IIDMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX,October 16, 2015
D-0370-2016Class IIL-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, October 16, 2015
D-0384-2016Class IIMethylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, SuiOctober 16, 2015
D-0378-2016Class IIThiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, DOctober 16, 2015
D-0340-2016Class IIEDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110October 16, 2015
D-0373-2016Class IIPyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, DaOctober 16, 2015