Downing Labs, LLC
Downing Labs, LLC appears in FDA public data with 48 recalls, 0 510(k) clearances, 7 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0355-2016, Class II) was initiated on October 16, 2015.
Summary
- Total Recalls
- 48
- 510(k) Clearances
- 0
- Inspections
- 7
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0355-2016 | Class II | HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, | October 16, 2015 |
| D-0377-2016 | Class II | Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, | October 16, 2015 |
| D-0341-2016 | Class II | Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL vial, Rx on | October 16, 2015 |
| D-0342-2016 | Class II | Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, | October 16, 2015 |
| D-0375-2016 | Class II | Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, D | October 16, 2015 |
| D-0364-2016 | Class II | Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, | October 16, 2015 |
| D-0359-2016 | Class II | DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, | October 16, 2015 |
| D-0384-2016 | Class II | Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Sui | October 16, 2015 |
| D-0378-2016 | Class II | Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, D | October 16, 2015 |
| D-0349-2016 | Class II | Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas | October 16, 2015 |
| D-0338-2016 | Class II | L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dal | October 16, 2015 |
| D-0356-2016 | Class II | Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dal | October 16, 2015 |
| D-0339-2016 | Class II | L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, | October 16, 2015 |
| D-0345-2016 | Class II | Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110 | October 16, 2015 |
| D-0351-2016 | Class II | Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Su | October 16, 2015 |
| D-0373-2016 | Class II | Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Da | October 16, 2015 |
| D-0353-2016 | Class II | Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxy | October 16, 2015 |
| D-0374-2016 | Class II | DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, | October 16, 2015 |
| D-0380-2016 | Class II | Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwe | October 16, 2015 |
| D-0371-2016 | Class II | Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dall | October 16, 2015 |