Drug product
Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.
D-1406-2012
Product summary
- Event
- Event 62442
- Status
- Terminated
- Classification
- Class III
- Quantity
- 24,423 bottles
- Official record key
drug-enforcement:D-1406-2012
Official wording
Reason: Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.
Code information: Lot number 120502276, Expiration date 05/2015, UPC Code 08807/11/0 -- revision number 08807/11/0. Lot number 120201286, Expiration date 03/2015, UPC Code 08807/11/0.
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up