July 2019 FDA Recall Drug by Preferred Pharmaceuticals, Inc
D-1491-2019 - CGMPs Deviations

This Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc on July 18, 2019 for the product Drug. The FDA reported the reason for recall as cgmps deviations. The product was distributed in CA, FL and the recall is currently terminated.

Recall Number: D-1491-2019

Reason for Recall
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Initiated
07-18-2019
Reported
07-31-2019
Quantity
171 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83370
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Preferred Pharmaceuticals, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, FL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-24-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : L2117Q, Batch: 12211717, Exp. 09/2019; F2818H, Batch: 06281808, Exp. 11/2019; B1819T, Batch: B1819T001 to B1819T048 (Inclusive), Exp. 05/2020.