GLYCOPYRROLATE Recall D-0091-2023
Description: Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
GLYCOPYRROLATE Recall D-0091-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0091-2023 |
| Event ID | 91390 |
| Brand | GLYCOPYRROLATE |
| Generic Name | GLYCOPYRROLATE |
| Manufacturer | GLYCOPYRROLATE |
| Active Substance | GLYCOPYRROLATE |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 1237 cartons |
| Recall Reason | Failed impurities/degradation specifications: Out of specification for unknown impurities. |
| Drug Classification | Class II |
| Drug Code Info | 20230104 |
| Product NDC | 50268-363 |
| Recall Initiation Date | 20221222 |
| Report Date | 20230104 |
| Classification Date | 20221228 |
| Address | 615 N 1st St Pulaski, TN 38478-2403 United States |
| Recalling Firm | AVKARE LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | V92SO9WP2I |
| Drug Application Number | ANDA202675 |
| Structured Product Labeling (SPL ID) | df2243cd-68f0-71d6-e053-2995a90ac9ba |
| Structured Product Labeling (SPL Set ID) | bd497783-e2d1-130c-e053-2995a90a7fb9 |
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