FDA recall D-0266-2023

McGuff Compounding Pharmacy Services, Inc. · Class II · 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.

Reason for recall

Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2022-12-08
Report date
2023-02-22
Termination date
2023-04-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Ana, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0266-2023