Drug product
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.
D-0266-2023
Product summary
- Event
- Event 91498
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 vials
- Official record key
drug-enforcement:D-0266-2023
Official wording
Reason: Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Code information: Lot: 22K1681, initial BUD: 12/18/2022, extended BUD: 1/27/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter