Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1406-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 28, 2012
- FDA report date
- Jul 11, 2012
- Quantity
- 24,423 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Health Plus Incorporated
Original FDA data
Every field from FDA enforcement report D-1406-2012, exactly as published.
Show all FDA fields
- City
- Chino
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 62442
- Address
- 13837 Magnolia Ave
- 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.
- Postal code
- 91710
- Report date
- Jul 11, 2012
- Product type
- Drugs
- Recall number
- D-1406-2012
- Classification
- Class III
- Recalling firm
- Health Plus Incorporated
- Product quantity
- 24,423 bottles
- Termination date
- Jan 15, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 28, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 3, 2012