Medications & Supplements/Prescription Drugs

McGuff Thiamine and Riboflavin Injections Recalled for Particulate Matter

Agency Publication Date: February 10, 2023

Summary

McGuff Compounding Pharmacy Services, Inc. is recalling 266 vials of Thiamine Hydrochloride and Riboflavin injections due to the presence of foreign particulate matter found in vials at the pharmacy. The recall includes 11 single-use 2 mL vials and 255 multiple-use 30 mL vials meant for intramuscular or intravenous injection. No injuries or adverse events have been reported to date, but the pharmacy initiated the recall voluntarily after discovering the foreign substances.

Risk

Injecting a medication that contains foreign particles can cause local irritation, inflammation, or more serious complications such as organ damage or blood clots if the material travels through the bloodstream. Because these drugs are administered directly into the muscle or vein, the presence of any foreign substance poses a potential health risk.

What You Should Do

This recall affects Thiamine Hydrochloride (Vitamin B1) and Riboflavin (Vitamin B2) injections in 2 mL single-use vials and 30 mL multiple-use vials produced by McGuff Compounding Pharmacy Services, Inc.
Check your supply for the following lot numbers and Beyond Use Dates (BUD): 2 mL vials of Lot 22K1681 (BUD 1/27/2023), and 30 mL vials of Lot 22K1661 (BUD 1/27/2023) or Lot 22J2401 (BUD 12/19/2022).
Stop using the recalled product immediately and ensure it is quarantined to prevent further use.
Contact McGuff Compounding Pharmacy Services, Inc. or your distributor directly to arrange for the return of the affected medication.
If you have health concerns or believe you have experienced an adverse reaction related to these injections, contact your healthcare provider or pharmacist immediately.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Thiamine Hydrochloride and Riboflavin Injection (2 mL)

Variants: Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL), 2 mL Sterile Single Use Vial, Preservative-Free

Lot Numbers:

22K1681 (BUD 1/27/2023)

Compounded for a licensed professional or patient use; Rx Only.

Product: Thiamine Hydrochloride and Riboflavin Injection (30 mL)

Variants: Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL), 30 mL Sterile Multiple Use Vial

Lot Numbers:

22K1661 (BUD 1/27/2023)

22J2401 (BUD 12/19/2022)

Compounded for a licensed professional or patient use; Rx Only.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91498

Status: Resolved

Manufacturer: McGuff Compounding Pharmacy Services, Inc.

Sold By: McGuff Compounding Pharmacy Services, Inc.

Manufactured In: United States

Units Affected: 2 products (11 vials; 255 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 · 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.

Summary

Risk

What You Should Do

This recall affects Thiamine Hydrochloride (Vitamin B1) and Riboflavin (Vitamin B2) injections in 2 mL single-use vials and 30 mL multiple-use vials produced by McGuff Compounding Pharmacy Services, Inc.

Check your supply for the following lot numbers and Beyond Use Dates (BUD): 2 mL vials of Lot 22K1681 (BUD 1/27/2023), and 30 mL vials of Lot 22K1661 (BUD 1/27/2023) or Lot 22J2401 (BUD 12/19/2022).

Stop using the recalled product immediately and ensure it is quarantined to prevent further use.

Contact McGuff Compounding Pharmacy Services, Inc. or your distributor directly to arrange for the return of the affected medication.

If you have health concerns or believe you have experienced an adverse reaction related to these injections, contact your healthcare provider or pharmacist immediately.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Affected Products

Product: Thiamine Hydrochloride and Riboflavin Injection (2 mL)

Variants: Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL), 2 mL Sterile Single Use Vial, Preservative-Free

Lot Numbers:

22K1681 (BUD 1/27/2023)

Compounded for a licensed professional or patient use; Rx Only.

Product: Thiamine Hydrochloride and Riboflavin Injection (30 mL)

Variants: Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL), 30 mL Sterile Multiple Use Vial

Lot Numbers:

22K1661 (BUD 1/27/2023)

22J2401 (BUD 12/19/2022)

Compounded for a licensed professional or patient use; Rx Only.