Home / Recalls / Downing Labs, LLC / D-0353-2016

D-0353-2016 Class II Terminated

Recalled by Downing Labs, LLC — Dallas, TX

Recall Details

Product Type
Drugs
Report Date
November 25, 2015
Initiation Date
October 16, 2015
Termination Date
September 22, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2189 vials

Product Description

Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

Code Information

All lots

Other recalls by Downing Labs, LLC

  • D-0377-2016 Class II — Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, (October 16, 2015)
  • D-0357-2016 Class II — EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LL (October 16, 2015)
  • D-0341-2016 Class II — Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/ (October 16, 2015)
  • D-0364-2016 Class II — Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing Labs, (October 16, 2015)
  • D-0342-2016 Class II — Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)1 (October 16, 2015)
  • D-0359-2016 Class II — DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, S (October 16, 2015)
  • D-0370-2016 Class II — L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 Mc (October 16, 2015)
  • D-0366-2016 Class II — B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite (October 16, 2015)
  • D-0384-2016 Class II — Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC (October 16, 2015)
  • D-0371-2016 Class II — Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen (October 16, 2015)