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 Hydroxyurea 100 mg/1 mL Suspension 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 Progest 200 mg/1 mL Cream due to inspection findings regarding sterility and stability data.
Health Innovations Pharmacy is recalling Phospholine Iodide 0.03% Opth Drops due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling Nortriptyline 10 mg/5 mL Suspension due to inspection findings regarding sterility and stability data.
Health Innovations Pharmacy is recalling Naltrexone 4.5 mg capsules because inspection findings indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling Ciprodex with Amphoteracin B ear drops due to lack of assurance of sterility and stability data.
Health Innovations Pharmacy is recalling Pyrimethamine 2 mg/1 mL Suspension because inspection findings raised concerns about sterility and stability data.
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 Colchicine 0.6 mg capsules because inspection observations indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling Keto 10%-Gabap 10%-Ketamine 2% Cream because inspection findings indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling Nifedipine 0.2% - Lidocaine 2% Jelly due to sterility and stability concerns. The recall covers all lots distributed in North Carolina.
Health Innovations Pharmacy is recalling Diclo 3% - Bacl 2% - Cyclo 2% - Lidoc 2% Cream because inspection observations indicate a lack of assurance of 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 Hydrocortisone 1.6 mg/0.5 mL Suspension due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling Hydroquinone 10% Cream due to quality control issues affecting sterility and stability data.
Health Innovations Pharmacy is recalling Qsymia capsules due to inspection findings regarding 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 Trimix #1 (Original) Injection because inspection findings raised concerns about sterility and stability data.
Health Innovations Pharmacy is recalling all lots of Pregnenolone 20 mg SR Capsules due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling Sodium Tetradecyl 1% Injection due to inspection findings regarding sterility and stability data.
Health Innovations Pharmacy is recalling Ibuprofen 10% cream in North Carolina due to quality control issues affecting sterility and stability data.
Health Innovations Pharmacy is recalling Nadolol 10 mg/1 mL Suspension due to lack of assurance of sterility and stability data supporting the expiry date.
Health Innovations Pharmacy is recalling Fortifed Tobramycin 15 mg/1 mL ophthalmic solution due to lack of assurance of sterility and stability data.
Health Innovations Pharmacy is recalling Spironolactone 5 mg/mL Suspension due to quality control issues affecting sterility and stability data.