D-0917-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 19, 2023
- Initiation Date
- July 3, 2023
- Termination Date
- October 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2348 vials
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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025