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Stop using now Drug recall · FDA · Published July 3, 2023

Accord Healthcare recalls Bivalir: Particulate fiber in injection vials

Accord Healthcare recalls 10 vials of Bivalirudin 250mg injection due to fiber particles. This may cause serious injury if injected. Stop using and contact for return.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0918-2023DrugAccord Healthcare ›
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Contact the company

Recalling firmAccord Healthcare, Inc.1009 Slater Rd Ste 210B · Durham, NC 27703-8446
✎ GovInfoNow plain-language explainer

Accord Healthcare is recalling 10 vials of Bivalirudin 250mg injection because they contain fiber particles. This could cause serious injury if the product is injected. Read more at govinfonow.com/recall/33394-accord-healthcare-recalls-bivalir-particulate-fiber-in-injection-vials.

Source Summary by GovInfoNow · govinfonow.com/recall/33394-accord-healthcare-recalls-bivalir-particulate-fiber-in-injection-vials · Updated August 17, 2026 · FDA enforcement record: FDA #D-0918-2023

Cite this page

“Accord Healthcare recalls Bivalir: Particulate fiber in injection vials.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33394-accord-healthcare-recalls-bivalir-particulate-fiber-in-injection-vials. Based on FDA recall #D-0918-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0918-2023%22&limit=1).

Accord Healthcare, Inc. voluntarily recalled Bivalirudin for Injection 250 mg due to particulate matter identified as fiber, according to the FDA on July 3, 2023.

How to tell if you have it

  • Brand: Accord Healthcare
  • Product: Bivalirudin for Injection 250 mg, 10 Single-Dose Vials
  • NDC: 16729-275-67
  • Lot #: M2212070
  • Exp. date: 08/2024

The hazard

The recall addresses the presence of particulate matter identified as fiber in the drug product.

Context

GovInfoNow's records show Accord Healthcare, Inc. has 16 other recalls on record since December 20, 2016. Other recent recalls of similar products include Accord IMULDOSA Injection Recall: Sterility Risk in Single-Dose Vials (June 10, 2026), American Regent Papaverine HCl Injection Recall: Particulate Matter Hazard (July 24, 2026), and Mallinckrodt Acthar Gel 5mL Vial Recall: Particulate Matter Hazard (August 6, 2026).

How to tell if you have this one

Check for the product name Bivalirudin 250mg injection, 10 single-dose vials, manufactured by Accord Healthcare. The lot number M2212070 is part of the affected batch.

  • Brand
    Accord Healthcare
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide within the United States
Recall numberProduct, codes & lotsQuantityNDC
D-0917-2023Atropine 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.; Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/20252348 vials16729-512-05, 16729-512-43
D-0918-2023Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.; Lot #: M2212070 Exp. date 08/20241680 vials16729-275-03, 16729-275-67
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Now

    Discard the vials immediately if you have the affected lot number M2212070.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 16 months after the firm started it.

1. Firm started the recall: Jul 3, 202312. FDA classified it Class II: Jul 13, 202323. Published in FDA’s Enforcement Report: Jul 19, 202334. FDA terminated the recall: Oct 17, 2024420232024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Other Accord Healthcare recalls

ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b)
August 6, 2026ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare,
June 8, 2026

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0918-2023 (July 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0918-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA