GLYCOPYRROLATE Recall D-0087-2023
Description: Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
GLYCOPYRROLATE Recall D-0087-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0087-2023 |
| Event ID | 91319 |
| Brand | GLYCOPYRROLATE |
| Generic Name | GLYCOPYRROLATE |
| Manufacturer | GLYCOPYRROLATE |
| Original Package? | 1 |
| Active Substance | GLYCOPYRROLATE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA and Puerto Rico. |
| Quantity | 7344 bottles |
| Recall Reason | Failed Impurities/Degradation Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20221228 |
| Product NDC | 13107-014 13107-015 |
| Recall Initiation Date | 20221216 |
| Report Date | 20221228 |
| Classification Date | 20221222 |
| Address | 2400 US Highway 130 Dayton, NJ 08810-1519 United States |
| Recalling Firm | Aurolife Pharma, LLC |
| Unique Ingredient Identifier | V92SO9WP2I |
| Drug Application Number | ANDA202675 |
| Structured Product Labeling (SPL ID) | 4bbe80ee-835d-4e90-9b9c-24f6b1a535d6 |
| Structured Product Labeling (SPL Set ID) | 677f8495-a870-45b6-bb65-75b449f040ce |
| Similar To |