FDAFDA · Food and drugs·Recall number D-0917-2023
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.
Published July 19, 2023 · Recall initiated: July 3, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Particulate matter identified as fiber.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ATROPINE SULFATE
- Manufacturer
- Accord Healthcare, Inc.
- Distributor
- Nationwide within the United States
- UPC
- 0316729512053
- Lot
- Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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