FDA recall D-0267-2023

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.

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-0267-2023