Class I · High risk
SENNA Syrup
Microbial Contamination of Non-Sterile Product
Super Colon Cleanse
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.
Drug: Senna
- Recalling firm
- Health Plus Incorporated
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1406-2012 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Senna recalls
See all
Class II · Moderate risk
Senna (sennosides 8.8 mg)
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class II · Moderate risk
Senna (sennosides 8.8 mg)
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class II · Moderate risk
SDA Senna Syrup
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Geritrex Senna Syrup
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Other labeling / mix-up recalls from 2012
All labeling / mix-up recalls
Class I · High risk
Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate
Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
Class III · Low risk
Divalproex Sodium Delayed-Release Tablets
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Class III · Low risk
Bronkaid Dual Action Formula
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Class II · Moderate risk
Synthroid (Levothyroxine Sodium)
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
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