FDA Drug recall D-0736-2022
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
- terminated
- Published 2022-04-06
On 2022-04-06 the FDA classified a Class II recall of Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, Ea… by Aurolife Pharma, citing presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0736-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-17 |
| Published | 2022-04-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurolife Pharma |
| Distribution | US |
Product
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.
Reason
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Identifiers
| ndc | 13107-014-01 |
|---|---|
| ndc | 13107-015-01 |
| code_info | Lot: 01421008A1, Exp 03/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0736-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.