FDAClass IIIMay 21, 2014

Psyllium Fiber recall: Labeling Error

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

Why was Psyllium Fiber recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16)

Product
PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.
Recalling firm
Konsyl Pharmaceuticals Inc
Quantity
6286 Bottles
Distribution
USA including FL, MN, NY, OH, OR, PA, TX, SC and Puerto Rico; Dominican Republic.
Recall date
May 21, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls