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FDAJuly 18, 2019drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

preferred pharmaceuticalspreferred

UPCs

68788937303

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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