Neomycin Sulfate 3 recalled over manufacturing violations

Recall date

July 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Preferred Pharmaceuticals, Inc recalls Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Gen…

Recall number

D-1491-2019

FDA classification

Class II

Brand / firm

Preferred Pharmaceuticals, Inc

Sold / distributed

CA, FL

Why it was recalled

CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitrol, For External Use Only, Rx only, Mfg: Paddock Laboratories, LLC, Preferred Pharmaceuticals, Inc., The Physicians Solutions, Anaheim, CA, NDC 68788-9373-03.