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 all lots of Lansoprazole 3 mg/mL Suspension due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling Glycopyrrolate 0.2 mg/1 mL Suspension (Robinul) because inspection findings indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling Dexamethasone 4 mg/mL Iontophoresis solution because inspection findings raised concerns about 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 Pyridoxine 100 mg/1 mL Syrup because inspection findings indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling Hydrocortisone 1.6 mg/0.5 mL Suspension due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling Serum 50% BSS 50% Opth Drops due to lack of assurance of sterility and stability data. The recall covers all lots distributed in North Carolina.
Health Innovations Pharmacy is recalling Cyclandelate 200 mg capsules due to quality control issues affecting sterility and stability data.
Health Innovations Pharmacy is recalling Cyanocobalamin 2000mcg/1ml Injection due to inspection findings regarding sterility and stability data.
Health Innovations Pharmacy is recalling Voriconazole 1% Opth Drops due to quality control issues affecting 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 Hydroxyurea 100 mg/1 mL Suspension because inspection findings indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling Triest 5 mg - Progest 150 mg capsules due to lack of assurance of sterility and stability data.
Health Innovations Pharmacy is recalling T4 66mcg - T3 10mcg SR Capsules due to inspection findings regarding sterility and stability data.
Health Innovations Pharmacy is recalling Coconut Oil Suppositories due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling Thymol 2% Solution because inspection findings indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling Carvedilol 1.25 mg/mL due to quality control issues affecting sterility and stability data.
Health Innovations Pharmacy is recalling Methylcobalamin 1000 mcg/mL Injection due to quality control issues affecting 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 Nexium 2 mg/1 mL Solution due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling Folic Acid 2 mg/1 mL Suspension due to quality control issues affecting sterility and stability data.
Health Innovations Pharmacy is recalling Testosterone 100 mg/1 mL Injection due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling Progest 200 mg/1 mL Cream due to inspection findings regarding sterility and stability data.
Health Innovations Pharmacy is recalling Glycerin 98.5% Opth. Solution because inspection observations indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling Nortriptyline 10 mg/5 mL Suspension due to inspection findings regarding sterility and stability data.