FDA (Drugs) recall action 77959
The FDA (Drugs) publishes a recall like this one as 16 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 16 pages.
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.
Bella Pharmaceuticals is recalling 6 bottles of Phenylephrine 2.5%/Tropicamide 1% Ophthalmic Solution due to a lack of assurance of sterility.
Bella Pharmaceuticals is recalling Mannitol 20% 10 mL vials because the company cannot ensure the product is sterile.
Bella Pharmaceuticals is recalling 45 vials of B-Complex due to a lack of assurance of sterility. The affected lot is BPBC3080517, expiring 2/5/18.
Bella Pharmaceuticals is recalling 644 vials of Fluorescein Sodium due to a lack of assurance of sterility. The affected lot was distributed nationwide.
Bella Pharmaceuticals is recalling specific lots of L-Glutamine 100mg vials because the company cannot guarantee the product is sterile.
Bella Pharmaceuticals is recalling 82 vials of PF-Glutathione 200mg/ml because the product lacks assurance of sterility.
Bella Pharmaceuticals is recalling Lidocaine Ophthalmic Gel 3.5% because the product lacks assurance of sterility.
Bella Pharmaceuticals is recalling Magnesium Chloride 200mg vials because the company cannot ensure the product is sterile.
Bella Pharmaceuticals is recalling specific lots of Calcium chloride 10% vials because the company cannot ensure the product is sterile.
Bella Pharmaceuticals is recalling 200 prefilled BevaDex syringes nationwide because the company cannot guarantee the product's sterility.
Bella Pharmaceuticals is recalling specific lots of Sodium Bicarbonate 8.4% vials because the company cannot ensure the product is sterile.
Bella Pharmaceuticals is recalling Methylcobalamin 10mg vials because the company cannot ensure the product is sterile.
Bella Pharmaceuticals is recalling MIC 25/50/50 vials because the company cannot ensure the product is sterile. The recall affects 5 vials distributed nationwide.
Bella Pharmaceuticals is recalling 7 vials of Methylcobalamin 10mg due to a lack of assurance of sterility. The product was distributed nationwide in the United States.
Bella Pharmaceuticals is recalling 2,334 Bevacizumab prefilled syringes nationwide due to a lack of assurance of sterility.
Bella Pharmaceuticals is recalling G.A.C 25/100/250mg vials because the company cannot ensure the product is sterile.