Drug product
PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.
D-1315-2014
Product summary
- Event
- Event 68052
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6286 Bottles
- Official record key
drug-enforcement:D-1315-2014
Official wording
Reason: Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
Code information: Lot #: A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16)
Distribution pattern: USA including FL, MN, NY, OH, OR, PA, TX, SC and Puerto Rico; Dominican Republic.
Derived failure modes
-
Labeling or packaging
Labeling: Label Error