August 2019 FDA Recall Drug by Preferred Pharmaceuticals, Inc
D-1877-2019 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc on August 29, 2019 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Product was distributed to 1 physician in Gainesville Florida. and the recall is currently terminated.

Recall Number: D-1877-2019

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
08-29-2019
Reported
10-02-2019
Quantity
79 (90 ct.) bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83711
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 1 physician in Gainesville Florida.
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.
Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09

Batch or Lot Expiration Information

Lot# : G0219K, Exp 3/2021; C1419E, Exp 3/2021