Class III · Low risk
Psyllium Fiber
Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
Leader Fiber Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1.
Affected NDC
37205-0372-78
Compare with the code on your package — it is the most precise check available.
Drug: Psyllium
- Recalling firm
- Raritan Pharmaceuticals, Inc.
- NDC code
- 37205-372-78
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-024-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Psyllium recalls
See all
Class II · Moderate risk
DRxChoice Fiber Capsules
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class II · Moderate risk
Premier Value Fiber Capsules
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class II · Moderate risk
Simply Right Healthcare Fiber Capsules
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class II · Moderate risk
Berkley & Jensen Fiber Capsules
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Other recalls by Raritan Pharmaceuticals, Inc.
All 2012 recalls
Class II · Moderate risk
CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz
CGMP Deviations
Class II · Moderate risk
Kids' Relief Ear Relief Oral Liquid 0.85 fl oz.
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
DRxChoice Fiber Capsules
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
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