FDA (Drugs) recall action 83397
The FDA (Drugs) publishes a recall like this one as 11 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 11 pages.
Lack of Processing Controls
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.
Wise Pharmacy is recalling 27 vials of Dexamethasone Sodium Phosphate Injection because of a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Wise Pharmacy is recalling 14 vials of compounded Papaverine/Phentolamine/Alprostadil/Atropine injectable due to a lack of processing controls.
Wise Pharmacy is recalling Acetylcysteine 2% Otic Drops due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Wise Pharmacy is recalling Gentamicin Irrigation Solution due to a lack of processing controls. The affected product was distributed in Colorado, Texas, and Wyoming.
Wise Pharmacy is recalling 8 vials of Papaverine/Phentolamine Injectable due to lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Wise Pharmacy is recalling 97 vials of compounded Papaverine/Phentolamine/Alprostadil injectable due to a lack of processing controls.
Wise Pharmacy is recalling 84 vials of compounded Papaverine/Phentolamine/Alprostadil injectable due to a lack of processing controls.
Wise Pharmacy is recalling 32 vials of compounded Papaverine/Phentolamine/Alprostadil injectable due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Wise Pharmacy is recalling specific lots of compounded Papaverine/Phentolamine/Alprostadil injectable vials due to a lack of processing controls.
Wise Pharmacy is recalling Tobramycin Irrigation 80 mg/1000 mL Solution due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Wise Pharmacy is recalling Alprostadil 100 mcg/mL Injectable vials due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.