August 2021 FDA Recall Drug by The Harvard Drug Group
D-0289-2022 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by The Harvard Drug Group on August 3, 2021 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0289-2022

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
08-03-2021
Reported
12-29-2021
Quantity
2,239 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88811
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.
The Harvard Drug Group
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-16-2023
Product Description About Product Description
Full technical description of the product.
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40

Batch or Lot Expiration Information

Lot# Lot, expiry: Lot H00005, exp 01/2022; Lot H00006, exp 04/2022; Lot H00007, exp 07/2022