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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

STAQ Pharma Ropivacaine HCl Injection Recalled for Potential Bag Leaks

Agency Publication Date: December 7, 2023
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Summary

STAQ Pharma, Inc. is recalling 2,616 bags of Ropivacaine HCl 0.2% PF in Sodium Chloride (1,000 mg/500 mL) Injection. This recall was initiated after reports of leaking bags and structural concerns caused by a manufacturing defect at the bag supplier's facility. While no injuries have been reported, a leaking bag can compromise the sterility of the medication or result in an incorrect dose being administered to a patient. Hospitals and clinics should immediately identify and stop using any affected bags from the nine specific lots included in this recall.

Risk

Leaking bags can lead to a loss of product sterility or an incomplete dosage being delivered to patients. This defect could potentially cause infections or treatment failure in clinical settings.

What You Should Do

  1. This recall affects STAQ Pharma Ropivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, sold in 500 mL bags (NDC 73177-0109-26).
  2. Identify affected bags by checking the lot number and expiration date printed on the packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact STAQ Pharma or your distributor to arrange for the return of any unused bags.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

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: ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection (500 mL)
Variants: 500 mL bags, Rx only
Lot Numbers:
23109472A (Exp. date 03/10/2024)
23109473A (Exp. date 03/11/2024)
23109474A (Exp. date 03/13/2024)
23109491A (Exp. date 03/16/2024)
23109492A (Exp. date 03/19/2024)
23109501A (Exp. date 03/25/2024)
23109520A (Exp. date 04/10/2024)
23109521A (Exp. date 04/13/2024)
23109522A (Exp. date 04/03/2024)
NDC:
73177-0109-26

The source of the issue was bag manufacturer Lot # 134142-001A which failed internal quality control tests for leaks.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93505
Status: Resolved
Manufacturer: STAQ Pharma, Inc.
Sold By: Wholesalers; Hospitals; Surgical Centers
Manufactured In: United States
Units Affected: 2616 bags
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.