March 2020 FDA Recall Drug by Par Pharmaceutical Inc.
D-1071-2020 - Failed Impurities/Degradation Specification

This Class II drug recall was voluntarily initiated by Par Pharmaceutical Inc. on March 30, 2020 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specification. The product was distributed in Product was distributed within the United States. and the recall is currently terminated.

Recall Number: D-1071-2020

Reason for Recall
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Initiated
03-30-2020
Reported
04-08-2020
Quantity
29,352 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85333
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.
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.
Product was distributed within the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01

Batch or Lot Expiration Information

Lot# 32809101, Exp 3/2021