Drug product
Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.
D-0267-2023
Product summary
- Event
- Event 91498
- Status
- Terminated
- Classification
- Class II
- Quantity
- 255 vials
- Official record key
drug-enforcement:D-0267-2023
Official wording
Reason: Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Code information: Lot: 22K1661, initial BUD: 12/18/2022, extended BUD: 1/27/2023; 22J2401, BUD: 12/19/2022.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter