FDA (Drugs) recall action 80890
The FDA (Drugs) publishes a recall like this one as 12 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 12 pages.
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
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.
Auro Pharmacies, Inc. is recalling 40 vials of Folic Acid injectable due to inadequate processes and equipment to assure sterility.
Auro Pharmacies is recalling 167 vials of Calcium Gluconate injectable because processes and equipment were inadequate to assure sterility.
Auro Pharmacies is recalling 43 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure product sterility.
Auro Pharmacies, Inc. is recalling 90 vials of Methyl-Cobalamin injectable because inadequate processes and equipment were used to assure sterility.
Auro Pharmacies is recalling 11 vials of Testosterone Enanthate/Cypionate injectable because the manufacturer could not assure the sterility of the product.
Auro Pharmacies is recalling 183 vials of Glutathione injectable because inadequate processes and equipment were used to assure the sterility of the product.
Auro Pharmacies, Inc. is recalling 91 vials of Dexpanthenol injectable due to inadequate processes and equipment to assure sterility.
Auro Pharmacies is recalling 74 vials of Methyl-Cobalamin injectable because the manufacturer could not assure the sterility of the product.
Auro Pharmacies is recalling 32 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure the sterility of the product.
Auro Pharmacies, Inc. is recalling 114 vials of Methyl-Cobalamin injectable because inadequate processes and equipment failed to assure product sterility.
Auro Pharmacies is recalling 39 vials of CoEnzyme-Q10 injectable because inadequate processes and equipment failed to assure product sterility.
Auro Pharmacies is recalling 81 vials of Methyl-Cobalamin injectable because processes and equipment were inadequate to assure sterility.