Health Plus Super Colon Cleanse Recalled for Labeling Error
Health Plus Incorporated is recalling Super Colon Cleanse capsules because the Drug Facts label incorrectly describes the active ingredient per dose instead of per capsule.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the unit of measurement for the active ingredient.
Plain-English summary
Health Plus Incorporated is voluntarily recalling 24,423 bottles of Super Colon Cleanse, a stimulant laxative containing 140 mg of Senna per capsule. The product was distributed nationwide.
The recall was initiated due to a labeling error in the Drug Facts box. The label incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg, whereas it should correctly state "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg. The affected lots are 120502276 (expiration 05/2015) and 120201286 (expiration 03/2015), both with UPC Code 08807/11/0.
Consumers who have purchased this product should check their bottles for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact Health Plus Incorporated for further instructions.
The recalled product
- Product
- Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.
- Manufacturer
- Health Plus Incorporated
- Category
- Drug — Over-the-Counter Laxative
- Hazard
- Affected units
- 24,423
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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
Distributed nationwide across the United States.
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