FDA (Drugs) recall action 70656
The FDA (Drugs) publishes a recall like this one as 65 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 65 pages.
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
The agency’s own wording, quoted from the enforcement report.
Health Innovations Pharmacy is recalling DNCB 0.3% Ointment due to lack of assurance of sterility and stability data. The recall covers all lots distributed in North Carolina.
Health Innovations Pharmacy is recalling Cyanocobalamin 2000mcg/1ml Injection due to inspection findings regarding sterility and stability data.
Health Innovations Pharmacy is recalling Azithromycin 100 mg Rectal Suppositories because inspection findings indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling Sildenafil 10 mg/1 mL Suspension because inspection observations indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling Estradiol 0.01% Vaginal Cream due to inspection findings regarding sterility and stability data.
Health Innovations Pharmacy is recalling Methenamine/Phenyl Salicylate Capsules due to quality control issues that may affect sterility and stability.
Health Innovations Pharmacy is recalling Nitroglycerin 0.2% Compounded Cream because inspection findings indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling all lots of Lansoprazole 3 mg/mL Suspension due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling all lots of Rifampin 25 mg/1 mL Suspension due to inspection findings regarding sterility and stability data.
Health Innovations Pharmacy is recalling Boric Acid Vaginal Capsules due to quality control issues affecting sterility and stability data.
Health Innovations Pharmacy is recalling Nystatin 50,000 Units Suppositories due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling Levodopa 250 mg NSR Capsules due to quality control issues affecting sterility and stability data.
Health Innovations Pharmacy is recalling Fortified Vancomycin 25 mg/1 mL Opth Drops due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling Coconut Oil Suppositories due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling Cyclandelate 200 mg capsules due to quality control issues affecting sterility and stability data.