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 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 186 vials of Methylcobalamin Buffered Injectable because the company cannot ensure the product is sterile.
Downing Labs, LLC is recalling Cyanocobalamin Buffered Injectable 3mg/mL vials because the company cannot ensure the product is sterile.
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 467 vials of L-Glutathione Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.
Downing Labs, LLC is recalling 320 vials of Magnesium Sulfate 50% Injectable because the company cannot assure the sterility of the product.
Downing Labs, LLC is recalling 178 vials of Folic Acid Injection because the company cannot ensure the product is sterile. The recall covers all lots distributed in the US and 17 other countries.
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 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 EDTA Disodium Injectable vials because the company cannot ensure the product is sterile.
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 98 vials of B12 Injection 12.5/12.5MG due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Downing Labs, LLC is recalling Taurine Injectable, 50mg/mL, 30mL vials due to a lack of assurance of sterility. The recall affects 123 vials distributed nationwide and internationally.
Downing Labs is recalling Methylcobalamin Buffered Injectable vials because the company cannot guarantee the product is sterile.
Downing Labs, LLC is recalling 34 vials of Testosterone Cypionate Injection due to a lack of assurance of sterility. The product was 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 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, 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.
Downing Labs, LLC is recalling 304 vials of Magnesium Sulfate Injection because the product lacks assurance of sterility. The affected vials were distributed nationwide and internationally.
Downing Labs, LLC is recalling L-Arginine Injection, 100mg/mL, 30mL vials because the company cannot assure the sterility of the product.
Downing Labs, LLC is recalling 160 vials of Magnesium Sulfate Injectable because the company cannot assure the sterility of the product.
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.