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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Accord Atropine Sulfate and Bivalirudin Injections Recalled for Fiber Particles

Agency Publication Date: July 13, 2023
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Summary

Accord Healthcare, Inc. is recalling 4,028 vials of Atropine Sulfate Injection and Bivalirudin for Injection because the products may contain particulate matter identified as fiber. These sterile medications were distributed nationwide to clinical settings. The firm initiated the voluntary recall after discovering the fiber particles during a routine inspection, as sterile injectable drugs must be free of any foreign matter to ensure patient safety.

Risk

Injecting medication that contains fiber particles can cause local irritation, inflammation, or swelling. In more serious cases, the particles could travel through the bloodstream and cause blood vessel blockage or damage to vital organs. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects Atropine Sulfate Injection (8 mg per 20 mL) and Bivalirudin for Injection (250 mg) vials manufactured for Accord Healthcare, Inc.
  2. For Atropine Sulfate (NDC 16729-512-43), check for lot numbers M2210154 (Exp 06/2025) or M2212575 (Exp 08/2025).
  3. For Bivalirudin (NDC 16729-275-67), check for lot number M2212070 (Exp 08/2024).
  4. Stop using the recalled product immediately.
  5. Contact the manufacturer or your distributor to arrange for the return of any affected inventory.
  6. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL)
Variants: 20 mL Multiple Dose Vials, 8 mg per 20 mL (0.4 mg per mL)
Lot Numbers:
M2210154 (Exp 06/2025)
M2212575 (Exp 08/2025)
NDC:
16729-512-43

Recall #: D-0917-2023; Quantity: 2348 vials

Product: Bivalirudin for Injection 250 mg
Variants: 10 Single-Dose Vials, 250 mg
Lot Numbers:
M2212070 (Exp 08/2024)
NDC:
16729-275-67

Recall #: D-0918-2023; Quantity: 1680 vials

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92639
Status: Resolved
Manufacturer: Accord Healthcare, Inc.
Sold By: Hospitals; Infusion Centers; Wholesalers; Authorized Distributors
Manufactured In: India, United States
Units Affected: 2 products (2348 vials; 1680 vials)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.