Status
Terminated
Drug Enforcement D-0917-2023
Presence of Particulate Matter: Particulate matter identified as fiber.
Classification
Class II
Report Date
July 19, 2023
Termination Date
October 17, 2024
Product Information
- 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.
- Product quantity
- 2348 vials
- Reason for recall
- Presence of Particulate Matter: Particulate matter identified as fiber.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Address
-
1009 Slater Rd Ste 210B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0917-2023
- Event ID
- 92639
- Recall initiation date
- July 3, 2023
- Center classification date
- July 13, 2023
- Code info
- Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025
- More code info
- —