Home / Recalls / Aurolife Pharma, LLC / D-0877-2023

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 August 28, 2024).

Recall Details

Product Type: Drugs
Report Date: June 28, 2023
Initiation Date: May 18, 2023
Termination Date: August 28, 2024
Voluntary/Mandated
Product Quantity

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

Other recalls by Aurolife Pharma, LLC

D-0087-2023 Class II — Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobin (December 16, 2022)
D-0736-2022 Class II — Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Au (March 17, 2022)
D-1872-2019 Class II — Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Dist (August 23, 2019)
D-1869-2019 Class II — Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, (August 23, 2019)
D-1870-2019 Class II — Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (August 23, 2019)
D-1874-2019 Class II — Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISC (August 23, 2019)
D-1873-2019 Class II — Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distr (August 23, 2019)
D-1865-2019 Class II — Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) (August 23, 2019)
D-1867-2019 Class II — fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, (August 23, 2019)
D-1871-2019 Class II — Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Auroh (August 23, 2019)