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FDAFDA · Food and drugs·Recall number D-1491-2019

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.

Published July 31, 2019 · Recall initiated: July 18, 2019

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Preferred Pharmaceuticals, Inc
Distributor
CA, FL
Lot
Lot #: L2117Q, Batch: 12211717, Exp. 09/2019; F2818H, Batch: 06281808, Exp. 11/2019; B1819T, Batch: B1819T001 to B1819T048 (Inclusive), Exp. 05/2020.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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