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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

SCA FentaNYL and Bupivacaine HCl Epidural Bags Recalled for Quality Deviations

Agency Publication Date: July 26, 2023
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Summary

SCA Pharmaceuticals is recalling 183 bags of FentaNYL (fentanyl) and Bupivacaine HCl (bupivacaine hydrochloride) in Sodium Chloride injection bags used for epidural anesthesia. This recall was initiated because units that were previously rejected for quality control issues were accidentally shipped to hospitals and clinics. No injuries have been reported to date, but the use of these rejected units could lead to patient harm due to potential sterility issues or incorrect drug concentrations.

Risk

The shipment of rejected units means these medications did not meet strict manufacturing and quality standards. Using these units could expose patients to contaminated medication or improper dosages during epidural administration.

What You Should Do

  1. This recall affects 250 mL bags of FentaNYL (500 mcg/250 mL) and Bupivacaine HCl (0.1%) in 0.9% Sodium Chloride, used for epidural injection (NDC 70004-0253-40).
  2. Check your inventory for lot number 1223047134 with a Use By date of 09/21/2023.
  3. Stop using the recalled product. Contact SCA Pharmaceuticals or your distributor to arrange for the return of any remaining units.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

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: FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bagby SCA Pharmaceuticals
Variants: 250 mL Bag, Injection for Epidural Use, fentaNYL Concentration - 2 mcg/mL, Single Dose Container
Lot Numbers:
1223047134 (Exp 09/21/2023)
NDC:
70004-0253-40

Recall #: D-0945-2023. Units affected: 183 bags. Recalled due to shipment of rejected units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92737
Status: Resolved
Manufacturer: SCA Pharmaceuticals
Sold By: hospitals; clinics
Manufactured In: United States
Units Affected: 183 bags
Distributed To: Kentucky, New Jersey

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.