D-1406-2012 Class III Terminated
FDA drug recall D-1406-2012 was initiated by Health Plus Incorporated on June 28, 2012 and is designated Class III. Reason for recall: 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 c… The recall status is terminated (terminated January 15, 2013). Affected quantity: 24,423 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 11, 2012
- Initiation Date
- June 28, 2012
- Termination Date
- January 15, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,423 bottles
Product Description
Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.
Reason for Recall
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.
Distribution Pattern
Nationwide
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.