Recall: D-0917-2023

Class II - Potentially Harmful

Class IIClassification

2023-07-03Initiated

TerminatedStatus

Accord Healthcare, Inc.Firm

Product

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

Presence of Particulate Matter: Particulate matter identified as fiber.

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.