Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.
Recall Number: D-0917-2023
Firm: Accord Healthcare, Inc.
Classification: Class II
Status: Terminated
Report Date: 20230719
Initiation Date: 20230703
Termination Date: 20241017
Reason for Recall
Presence of Particulate Matter: Particulate matter identified as fiber.
Product Description
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.