Downing Labs, LLC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
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-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-0363-2016Class IICalcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, SOctober 16, 2015
D-0356-2016Class IIChromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, DalOctober 16, 2015
D-0366-2016Class IIB12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754October 16, 2015
D-0383-2016Class IIMIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 MOctober 16, 2015
D-0349-2016Class IITaurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, DallasOctober 16, 2015
D-0350-2016Class IIMagnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, DOctober 16, 2015
D-0345-2016Class IIProcaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110October 16, 2015
D-0365-2016Class IIHydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, October 16, 2015
D-0351-2016Class IICyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, SuOctober 16, 2015
D-0355-2016Class IIHCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,October 16, 2015