D-0877-2023 Class III Terminated

Recalled by Aurolife Pharma, LLC — Dayton, NJ

FDA drug recall D-0877-2023 was initiated by Aurolife Pharma, LLC on May 18, 2023 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Aug 28, 2024).

Recall Details

Product Type
Drugs
Report Date
Jun 28, 2023
Initiation Date
May 18, 2023
Termination Date
Aug 28, 2024

Product Description

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide within the United States

Code Information

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

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0877-2023
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-0877-2023. Report a data issue: hello@regdatalab.com.