FDA (Drugs) recall action 72455
The FDA (Drugs) publishes a recall like this one as 48 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 48 pages.
Lack of Assurance of Sterility
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Downing Labs, LLC is recalling Thiamine HCl Injection, 100mg/mL, 30mL vials because the company cannot assure the sterility of the product.
Downing Labs, LLC is recalling 20 vials of Glucosamine HCL Injectable because the product lacks assurance of sterility. The recall covers all lots distributed in the US and internationally.
Downing Labs, LLC is recalling Acetyl-L-Carnitine and L-Carnitine injectable vials due to a lack of assurance of sterility. The products were distributed nationwide and internationally.
Downing Labs, LLC is recalling 287 vials of Sermorelin/GHRP-6/GHRP-2 Injection due to a lack of assurance of sterility. The product was distributed nationwide and in multiple international locations.
Downing Labs, LLC is recalling 881 vials of Procaine Injectables because the company cannot ensure the product is sterile. The affected vials were distributed in the US and 17 other countries.
Downing Labs, LLC is recalling MIC w/Methyl B-12 Preserved Injection vials because the company cannot assure the sterility of the product. The recall affects 49 vials distributed nationwide and internationally.
Downing Labs, LLC is recalling Riboflavin-5-Phosphate Injectable vials because the company cannot ensure the product is sterile.
Downing Labs, LLC is recalling 186 vials of Methylcobalamin Buffered Injectable because the company cannot ensure the product is sterile.
Downing Labs, LLC is recalling Thiotic Acid Injection because the company cannot ensure the product is sterile. The recall affects 7 vials distributed in the US and 17 other countries.
Downing Labs, LLC is recalling 315 vials of Methylcobalamin Injection Buffered 5mg/mL due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Downing Labs is recalling specific lots of Phosphatidylcholine/Deoxycholic Acid Injection because the company cannot assure the product's sterility.
Downing Labs, LLC is recalling MICML TRNDPPC Injection (Preserved) 10mL vials because the company cannot ensure the product is sterile.
Downing Labs, LLC is recalling DMAE Dimethylaminoethanol Injection due to a lack of assurance of sterility. The recall affects 16 vials distributed nationwide and internationally.
Downing Labs, LLC is recalling Green Tea (EGCG) Injectable vials because the company cannot ensure the product is sterile. The recall covers 23 vials distributed in the US and internationally.
Downing Labs, LLC is recalling Co-Enzyme Q-10 Injectable vials because the product lacks assurance of sterility. The recall covers all lots distributed in the US and internationally.
Downing Labs, LLC is recalling 225 vials of Potassium Chloride Injection due to a lack of assurance of sterility. The product was distributed nationwide and in multiple international markets.
Downing Labs, LLC is recalling Pyridoxine Injection, 100 mg/mL, 30mL vials due to a lack of assurance of sterility. The recall affects 280 vials distributed nationwide and internationally.
Downing Labs, LLC is recalling 74 vials of Zinc Sulfate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Downing Labs, LLC is recalling Piracetam Injection, 200mg/mL, 10mL vials due to a lack of assurance of sterility. The recall covers all lots distributed nationwide and internationally.
Downing Labs, LLC is recalling L-Glutamine Injectable vials because the company cannot assure the product's sterility. The recall covers all lots distributed in the US and internationally.
Downing Labs is recalling Methylcobalamin Buffered Injectable vials because the company cannot guarantee the product is sterile.
Downing Labs, LLC is recalling 29 vials of L-Tyrosine Injectable because the product lacks assurance of sterility. The affected product was distributed nationwide and in multiple international markets.
Downing Labs, LLC is recalling M.I.C Injection (Preserved) because the company cannot ensure the product is sterile. The recall affects 172 vials distributed in the US and internationally.