Class II · Moderate risk
thiamine HCl
Lack of Assurance of Sterility
Thiamine Hydrochloride 200 mg/2mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.
Drug: Thiamine
- Recalling firm
- McGuff Compounding Pharmacy Services, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0266-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Thiamine recalls
See all
Class II · Moderate risk
Thiamine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution
Presence of Particulate Matter.
Class II · Moderate risk
B-Complex
Presence of Particulate Matter.
Class II · Moderate risk
Thiamine/Ribofla/Niacinami/Dexpanth/Pyridox/Hydroxycobal 25mg/25mg/25mg/25mg/25mg/20mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Other recalls by McGuff Compounding Pharmacy Services, Inc.
All 2022 recalls
Class II · Moderate risk
Thiamine Hydrochloride 3000 mg/30 mL
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Class II · Moderate risk
Dimercaptopropanesulfonate Sodium
Presence of Particulate Matter: Particulates observed in vials release for dispensing.
Class II · Moderate risk
Lipoic Acid Injection
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.