Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

US Specialty Formulations Ethanol and B-Complex Injections Recalled

Agency Publication Date: June 6, 2022
Share:
Sign in to monitor this recall

Summary

US Specialty Formulations LLC has recalled 2,773 vials of Ethanol for Injection (95%) and B-Complex + Chromic Chloride injections because they may not be sterile. The recalled products include multi-dose vials used in medical treatments and were distributed nationwide to medical facilities and physician offices. No injuries or infections have been reported to date, but the company is taking this action as a precaution to ensure patient safety. Consumers and healthcare providers should identify the affected lots based on the labels on the 67 mL and 30 mL vials.

Risk

Injecting a product that is not sterile can introduce bacteria or other contaminants directly into a patient's body, which can cause serious and potentially life-threatening infections.

What You Should Do

  1. This recall affects Ethanol for Injection 95% (67 mL) and B-Complex + Chromic Chloride (30 mL) multi-dose vials manufactured by US Specialty Formulations LLC.
  2. For Ethanol for Injection (PN: 69389-06229), check for lot numbers 02RP1503A (Exp 30-Sep-22), 02RP1506A (Exp 31-Dec-22), and 02RP1516A (Exp 30-Jun-23).
  3. For B-Complex + Chromic Chloride (P/N: 234-15523), check for lot numbers 02RP1507A (Exp 30-Jun-22), 02RP1512A (Exp 30-Sep-22), 02RP1514A (Exp 31-Nov-22), and 02RP1515A (Exp 31-Dec-22).
  4. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Ethanol for Injection 95% (67 mL)by US Specialty Formulations
Variants: 95%, 67 mL Multi-Dose vial
Model:
69389-06229
Lot Numbers:
02RP1503A (Exp 30-Sep-22)
02RP1506A (Exp 31-Dec-22)
02RP1516A (Exp 30-Jun-23)

Distributed to medical facilities and physician's offices nationwide.

Product: B-Complex + Chromic Chloride (30 mL)by US Specialty Formulations
Variants: 30 mL Multi-Dose Vial, Packaged in 2 x 30 mL vials per carton
Model:
234-15523
Lot Numbers:
02RP1507A (Exp 30-Jun-22)
02RP1512A (Exp 30-Sep-22)
02RP1514A (Exp 31-Nov-22)
02RP1515A (Exp 31-Dec-22)

Ingredients include Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, and Chromic Chloride 0.003%.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90257
Status: Resolved
Manufacturer: US Specialty Formulations LLC
Sold By: medical facilities; physician's office
Manufactured In: United States
Units Affected: 2 products (781 vials; 1992 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.