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
Buy Me a Coffee

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

McGuff Compounding Pharmacy Services, Inc.: Lipoic Acid Injection Recalled Due to Particulate Matter Contamination

Agency Publication Date: January 16, 2020
Share:
Sign in to monitor this recall

Summary

McGuff Compounding Pharmacy Services is recalling 146 vials of Lipoic Acid Injection (also known as Alpha Lipoic Acid or Thioctic Acid) after filmy or cloudy particulate matter was found inside a vial. This prescription medication is used as an injectable supplement and was distributed in 30 mL multiple-dose vials. Consumers should check their medication for specific lot numbers and beyond-use dates to ensure they do not have the affected product.

Risk

The presence of particulate matter in a sterile injectable drug can cause serious health issues, including inflammation, allergic reactions, or blood vessel blockages (embolisms) if the particles are injected into the bloodstream. No injuries or adverse events have been reported to date for this specific recall.

What You Should Do

  1. Check your Lipoic Acid Injection (Alpha Lipoic Acid) 30 mL vials for Lot #: 18M0991, Preparation #: 390-2678, and a Beyond Usage Date of 06/15/2019.
  2. If you identify an affected vial, stop using the medication immediately and do not administer it.
  3. Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any concerns.
  4. Return any unused vials to the pharmacy where they were dispensed for a refund and further instructions.
  5. Contact McGuff Compounding Pharmacy Services at their Santa Ana, CA facility for more information regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Lipoic Acid Injection (Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial
Model:
Preparation #: 390-2678
Lot Numbers:
18M0991
Date Ranges: Beyond Usage Date: 06/15/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84618
Status: Resolved
Manufacturer: McGuff Compounding Pharmacy Services, Inc.
Sold By: McGuff Compounding Pharmacy Services, Inc.
Manufactured In: United States
Units Affected: 146 30 ml vials were dispensed
Distributed To: Nationwide
Agency Last Updated: January 29, 2020

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.