Product Safety Recalls

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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

Mandated?Voluntary: Firm initiated
Recall NumberD-0398-2023
Event ID91657
Original Package?1
DistributionUnited States including Puerto Rico and Canada
Quantity3,164 vials
Recall ReasonCGMP Deviations: recalling drug products following an FDA inspection.
Drug ClassificationClass II
Drug Code Info20230308
Product NDC16729-471 16729-472 16729-473
Drug UPC0316729471633 316729473316 316729473033
Recall Initiation Date20230207
Report Date20230308
Classification Date20230302
Address1009 Slater Rd Ste 210B
Durham, NC 27703-8446
United States
Recalling FirmAccord Healthcare, Inc.
Initial Notification Letter
Unique Ingredient IdentifierV92SO9WP2I
Drug Application NumberANDA213238
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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