FDA Drug recall D-0877-2023
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 1310…
- FDA Drug
- Class III
- terminated
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class III recall of Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 1310… by Aurolife Pharma, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0877-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-05-18 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurolife Pharma |
| Distribution | US |
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
Reason
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 13107-014-01 |
|---|---|
| ndc | 13107-015-01 |
| code_info | Lot #: 01421038A1, Exp. Date 05/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Aurolife Pharma
- Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-…
FDA Drug · Class II · 2022-12-28 · Aurolife Pharma - Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, Ea…
FDA Drug · Class II · 2022-04-06 · Aurolife Pharma - Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ…
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 727…
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma - Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK
FDA Drug · Class II · 2019-09-25 · Aurolife Pharma
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0877-2023%22
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