Atropine Sulfate Injection, Solution
FDA Recall NDC 16729-512
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Atropine Sulfate (NDC 16729-512). A significant event, classified as Class II, was initiated on Jul 03, 2023 by Accord Healthcare Inc.. The reported reason for this action was: "Presence of Particulate Matter: Particulate matter identified as fiber."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Particulate Matter: Particulate matter identified as fiber.
Jul 03, 2023
Jul 19, 2023
2348 vials
Recall Profile & Regulatory Data
Event ID
92639
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Oct 17, 2024
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.
Batch or Lot Expiration Information
Lot# : M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025
Affected Packages Involved in this Recall
16729-512-05Product
16729-512-43Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
