FDA recall D-0987-2022

Product

B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523

Reason for recall

Lack of Assurance of Sterility

Distribution

Product was distributed to medical facilities and a physician's office Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2022-05-24

Report date

2022-06-15

Termination date

2024-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0987-2022