D-1315-2014 Class III Terminated
FDA drug recall D-1315-2014 was initiated by Konsyl Pharmaceuticals Inc on April 1, 2014 and is designated Class III. Reason for recall: Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. The recall status is terminated (terminated May 26, 2016). Affected quantity: 6286 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 21, 2014
- Initiation Date
- April 1, 2014
- Termination Date
- May 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6286 Bottles
Product Description
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 Pattern
USA including FL, MN, NY, OH, OR, PA, TX, SC and Puerto Rico; Dominican Republic.
Code Information
Lot #: A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16)