Home / Recalls / Aurolife Pharma, LLC / D-0087-2023

D-0087-2023 Class II Ongoing

Recalled by Aurolife Pharma, LLC — Dayton, NJ

FDA drug recall D-0087-2023 was initiated by Aurolife Pharma, LLC on Dec 16, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is ongoing. Affected quantity: 7344 bottles.

Recall Details

Product Type: Drugs
Report Date: Dec 28, 2022
Initiation Date: Dec 16, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7344 bottles

Product Description

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, 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 in the USA and Puerto Rico.

Code Information

Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0087-2023
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.

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