January 2019 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-0428-2019 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on January 18, 2019 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-0428-2019

Reason for Recall
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Initiated
01-18-2019
Reported
02-06-2019
Quantity
88,090 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81930
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.
Mylan 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.
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.
10-09-2019
Product Description About Product Description
Full technical description of the product.
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.

Batch or Lot Expiration Information

Lot# : a) 3085490, 3085491, Exp 04/19; b) 3085492, 3085493, 3085494, 3085495, 3085496, Exp 04/19