Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx on...
FDA Recall #D-0917-2023 — Class II — July 3, 2023
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.
Reason for Recall
Presence of Particulate Matter: Particulate matter identified as fiber.
Recalling Firm
Accord Healthcare, Inc. — Durham, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2348 vials
Distribution
Nationwide within the United States
Code Information
Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated