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 T4 66mcg - T3 10mcg SR Capsules due to inspection findings 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 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 Renacidin Irrigation Solution due to quality control issues affecting sterility and stability data.
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 Estriol 5% Cream Vaginal Cream because inspection observations 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 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 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 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 Pyridoxine 100 mg/1 mL Syrup because inspection findings indicate a lack of assurance regarding 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 17-HP Hydroxyprogesterone 250mg/1ml Injection because inspection findings indicate a lack of assurance regarding 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 HCG 1000 Units/mL Injection because inspection findings raised concerns about sterility and stability data.
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 Voriconazole 1% Opth Drops due to quality control issues affecting 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 Dexamethasone 4 mg/mL Iontophoresis solution because inspection findings raised concerns about 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 EDTA 3% Eye Drops 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 DHEA 10 mg SR Capsules because inspection findings indicate a lack of assurance regarding sterility and stability data.
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 Verapamil HCl 15% Topical Cream due to lack of assurance of sterility and stability data.