February 2020 FDA Recall Drug by Par Pharmaceutical Inc.
D-0843-2020 - Labeling

This Class III drug recall was voluntarily initiated by Par Pharmaceutical Inc. on February 10, 2020 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0843-2020

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
Initiated
02-10-2020
Reported
02-19-2020
Quantity
9,936 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84912
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Par Pharmaceutical 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-17-2020
Product Description About Product Description
Full technical description of the product.
Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34.

Batch or Lot Expiration Information

Lot# Lot Number: 9698818; labeled expiration AUG 2022; actual expiration APR 2022