FDA recall D-0515-2022

Ultra Seal Corporation · Class II · drug

Product

ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

Reason for recall

cGMP deviations

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2022-01-24
Report date
2022-02-09
Termination date
2023-10-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
New Paltz, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0515-2022