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 Verapamil HCl 15% Topical Cream due to lack of assurance of sterility and stability data.
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 Laureth-P 1% Injection because inspection findings indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling Promethazine 25 mg/0.5 mL Gel because inspection observations indicate a lack of assurance of sterility and stability data.
Health Innovations Pharmacy is recalling EDTA 3% Eye Drops due to inspection findings regarding sterility and stability data.
Health Innovations Pharmacy is recalling Hydroquinone 10% Cream 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 Ibuprofen 10% cream in North Carolina due to quality control issues affecting 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 Leucovorin 1 mg/1 mL Suspension due to lack of assurance of sterility and stability data. The recall is limited to North Carolina.
Health Innovations Pharmacy is recalling HCG 1000 Units/mL Injection because inspection findings raised concerns about 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 Sodium Tetradecyl 1% Injection due to inspection findings regarding 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 Pyrimethamine 2 mg/1 mL Suspension because inspection findings raised concerns about 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 17-HP Hydroxyprogesterone 250mg/1ml Injection 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 all lots of Rifampin 25 mg/1 mL Suspension 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 Renacidin Irrigation Solution due to quality control issues affecting 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 Acetylcysteine 10% Opth 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.
Health Innovations Pharmacy is recalling Nitroglycerin 0.2% Compounded Cream because inspection findings indicate a lack of assurance regarding sterility and stability data.