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 |