March 2022 FDA Recall Glycopyrrolate by Aurolife Pharma, Llc
D-0736-2022 - Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by Aurolife Pharma, Llc on March 17, 2022 for the product Glycopyrrolate. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0736-2022

Reason for Recall
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Initiated
03-17-2022
Reported
04-06-2022
Quantity
4080 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89869
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.
Aurolife Pharma, LLC
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-25-2024
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.

Batch or Lot Expiration Information

Lot# Lot: 01421008A1, Exp 03/2023

Affected Packages Involved in this Recall

13107-014-01 Glycopyrrolate
13107-015-01 Glycopyrrolate