FDA recall D-1491-2019

Product

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.

Reason for recall

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

Distribution

CA, FL

Key facts

Status

Terminated

Initiation date

2019-07-18

Report date

2019-07-31

Termination date

2023-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1491-2019