FDA (Drugs) recall action 63305
The FDA (Drugs) publishes a recall like this one as 17 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 17 pages.
Non-Sterility
Lack of Assurance of Sterility
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
New England Compounding Center is recalling 9,062 vials of Methylprednisolone Acetate Injection because they may not be sterile. The recall is nationwide.
New England Compounding Center is recalling Lidocaine vials because the FDA determined there is a lack of assurance of sterility.
New England Compounding Center is recalling Isovue 200 mg/mL and 300 mg/mL vials nationwide due to a lack of assurance of sterility.
New England Compounding Center is recalling 165 vials of Glycerin 100% PF due to a lack of assurance of sterility. The product was distributed nationwide.
New England Compounding Center is recalling Omnipaque vials nationwide because the company cannot ensure the product is sterile.
New England Compounding Center is recalling Betamethasone Repository injections due to a lack of assurance of sterility. The recall covers all lot codes distributed nationwide.
New England Compounding Center is recalling specific Triamcinolone vials nationwide because the company cannot guarantee the products are sterile.
New England Compounding Center is recalling Hyaluronidase 150 u/ml PF vials nationwide because the FDA determined there is a lack of assurance of sterility.
New England Compounding Center is recalling Bupivacaine 0.25%, 0.5%, and 0.75% PF products because the agency cannot assure the sterility of the medication.
New England Compounding Center is recalling 3,822 vials of Methylprednisolone Acetate 80 mg/mL Injection nationwide due to non-sterility concerns.
New England Compounding Center is recalling 5,130 vials of Methylprednisolone Acetate Injection nationwide due to non-sterility concerns.
New England Compounding Center is recalling 23,897 vials of Methylprednisolone Acetate Injection nationwide due to non-sterility concerns.
New England Compounding Center is recalling Lidocaine/Dextrose 5%/7.5% PF nationwide due to a lack of assurance of sterility.
New England Compounding Center is recalling Betamethasone Sodium Phosphate injections due to a lack of assurance of sterility.
New England Compounding Center is recalling Dexamethasone Sodium Phosphate vials due to a lack of assurance of sterility.
New England Compounding Center is recalling Clonidine 100 mcg/mL vials nationwide due to a lack of assurance of sterility.
New England Compounding Center is recalling 54 vials of Saline 10% and 3% in 5 mL and 10 mL sizes because sterility could not be assured. The vials were distributed nationwide, and all lot codes are included.