FDA recall D-1315-2014

Konsyl Pharmaceuticals Inc · Class III · drug

Product

PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.

Reason for recall

Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.

Distribution

USA including FL, MN, NY, OH, OR, PA, TX, SC and Puerto Rico; Dominican Republic.

Key facts

Status
Terminated
Initiation date
2014-04-01
Report date
2014-05-21
Termination date
2016-05-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Easton, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1315-2014