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 Estriol 5% Cream Vaginal Cream because inspection observations indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling Baclofen 20 mg/4 mL Suspension 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 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 Ciprodex with Amphoteracin B ear drops due to lack of assurance of sterility and stability data.
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 all lots of Pregnenolone 20 mg SR Capsules due to quality control issues affecting sterility and stability.
Health Innovations Pharmacy is recalling BLT New Formula 20%/7%/7% samples because inspection observations indicate a lack of assurance regarding sterility and stability data.
Health Innovations Pharmacy is recalling DHEA 10 mg SR Capsules because inspection findings indicate a lack of assurance regarding 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 Phenylephrine 0.5% Solution due to quality control issues that present a risk to sterility and stability.
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 Levodopa 250 mg NSR Capsules due to quality control issues affecting sterility and stability data.
Health Innovations Pharmacy is recalling Warfarin 2.5 ng Lactose Free Capsules due to inspection findings regarding sterility and stability data.
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.