April 2014 FDA Recall Drug by Konsyl Pharmaceuticals Inc
D-1315-2014 - Labeling
This Class III drug recall was voluntarily initiated by Konsyl Pharmaceuticals Inc on April 1, 2014 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in USA including FL, MN, NY, OH, OR, PA, TX, SC and Puerto Rico; Dominican Republic. and the recall is currently terminated.
Recall Number: D-1315-2014
Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
04-01-2014
05-21-2014
6286 Bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Konsyl Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA including FL, MN, NY, OH, OR, PA, TX, SC and Puerto Rico; Dominican Republic.
05-26-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.
Batch or Lot Expiration Information
Lot# : A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16)
