FDA (Drugs) recall action 82278
The FDA (Drugs) publishes a recall like this one as 25 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 25 pages.
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
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.
Professional Compounding Pharmacy is recalling PGE1 40 mcg/ml injectable vials because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
The FDA is recalling compounded sodium chloride eye drops from Professional Compounding Pharmacy in Oregon due to insanitary conditions observed during compounding.
Health Solutions Pharmacy Center is recalling a compounded sterile injectable drug due to insanitary conditions observed during an FDA inspection.
Professional Compounding Pharmacy is recalling a compounded injectable drug because FDA inspectors observed insanitary conditions during its compounding.
Professional Compounding Pharmacy is recalling Acetyl-L-Cysteine 10% eye drops because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
Professional Compounding Pharmacy is recalling specific lots of Papaverine-Phentolamine-PGE1 Injectable because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
FDA is recalling compounded papaverine-phentolamine injectable due to insanitary conditions observed during compounding of sterile drugs.
Professional Compounding Pharmacy is recalling specific lots of compounded Papaverine-Phentolamine-PGE1 injectable because FDA inspectors observed insanitary conditions during the compounding process.
Professional Compounding Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL injectable because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
Professional Compounding Pharmacy is recalling Papaverine-Phentolamine 15-0.5mg/mL injectable vials because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
Professional Compounding Pharmacy is recalling compounded Papaverine-Phentolamine-PGE1 injectable due to insanitary conditions observed during a recent FDA inspection.
Professional Compounding Pharmacy is recalling PGE1-Lidocaine injectable products because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
Professional Compounding Pharmacy is recalling compounded papaverine-phentolamine-PGE1 injectable due to insanitary conditions observed during an FDA inspection.
The FDA is recalling compounded Papaverine-Phentolamine-PGE1 injectable products from Professional Compounding Pharmacy in Oregon due to insanitary conditions observed during compounding.
Professional Compounding Pharmacy is recalling a specific lot of Papaverine-Phentolamine-PGE1 injectable because FDA inspectors found insanitary conditions during the compounding of sterile drugs.
Professional Compounding Pharmacy is recalling Papaverine-Phentolamine-PGE1 injectable due to insanitary conditions observed during compounding.
Professional Compounding Pharmacy is recalling a compounded sterile injectable drug due to insanitary conditions observed during an FDA inspection.
Professional Compounding Pharmacy is recalling a compounded sterile injectable drug due to insanitary conditions observed during an FDA inspection.
Health Solutions Pharmacy Center is recalling compounded papaverine-phenolamine-PGE1 injectable vials because FDA inspectors observed insanitary conditions during the compounding process.
Professional Compounding Pharmacy is recalling compounded papaverine-phenolamine-PGE1 injections due to insanitary conditions observed during an FDA inspection.
Professional Compounding Pharmacy is recalling 12 prescriptions of Dexamethasone eye drops due to insanitary conditions observed during compounding.
FDA is recalling specific lots of Papaverine-Phentolamine-PGE1 Injectable due to insanitary conditions observed during compounding.
Health Solutions Pharmacy Center is recalling compounded Papaverine-Phentolamine-PGE1 injectables because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
Health Solutions Pharmacy Center Inc is recalling Papaverine-Phentolamine 30-0.5 mg/ml injectable due to insanitary conditions observed during compounding.
FDA is recalling compounded Papaverine-Phentolamine-PGE1 injectable vials from Professional Compounding Pharmacy due to insanitary conditions observed during compounding.