FDAClass IIJuly 19, 2023

Atropine Sulfate Injection recall: Particulate Matter

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…

Why was Atropine Sulfate Injection recalled?

Presence of Particulate Matter: Particulate matter identified as fiber.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025

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…
Recalling firm
Accord Healthcare, Inc.
Quantity
2348 vials
Distribution
Nationwide within the United States
Recall date
July 19, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls