GLYCOPYRROLATE Recall D-0398-2023
Description: Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 5mL vial NDC 16729-473-31 UPC 3 16729 47331 6; carton NDC 16729-473-03 UPC 3 16729 47303 3
GLYCOPYRROLATE Recall D-0398-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0398-2023 |
| Event ID | 91657 |
| Brand | GLYCOPYRROLATE |
| Generic Name | GLYCOPYRROLATE |
| Manufacturer | GLYCOPYRROLATE |
| Original Package? | 1 |
| Active Substance | GLYCOPYRROLATE |
| Drug Route | INTRAMUSCULAR |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 3,164 vials |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-471 16729-472 16729-473 |
| Drug UPC | 0316729471633 316729473316 316729473033 |
| Recall Initiation Date | 20230207 |
| Report Date | 20230308 |
| Classification Date | 20230302 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | V92SO9WP2I |
| Drug Application Number | ANDA213238 |
| Structured Product Labeling (SPL ID) | d393a343-b672-2587-e053-2995a90a3f5b |
| Structured Product Labeling (SPL Set ID) | 871797f0-697a-4a29-a37b-d06219e8f266 |
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