January 2020 FDA Recall Drug by Ncs Healthcare Of Kentucky Inc
D-0850-2020 - Failed Impurities/Degradation Specification

This Class II drug recall was voluntarily initiated by Ncs Healthcare Of Kentucky Inc on January 28, 2020 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0850-2020

Reason for Recall
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Initiated
01-28-2020
Reported
02-26-2020
Quantity
6929 blister cards

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84992
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.
NCS Healthcare of Kentucky 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.
02-19-2021
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.

Batch or Lot Expiration Information

Lot# : 8170-9004, Exp 01/2020