May 2023 FDA Recall Glycopyrrolate by Aurolife Pharma, Llc
D-0877-2023 - Failed Impurities/Degradation Specifications

This Class III drug recall was initiated by Aurolife Pharma, Llc on May 18, 2023 for the product Glycopyrrolate. 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-0877-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
05-18-2023
Reported
06-28-2023
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92379
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.
Aurolife Pharma, LLC
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2024
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Batch or Lot Expiration Information

Lot# : 01421038A1, Exp. Date 05/2023

Affected Packages Involved in this Recall

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