Class III · Low risk
Psyllium Fiber
Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
Up&Up Psyllium Fiber Supplement
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
Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by: Target Corp., Minneapolis, MN 55403, Made in USA, NDC 11673-059-87, UPC 3-68163-11926-8.
Affected NDC
11673-0059-87
Compare with the code on your package — it is the most precise check available.
Drug: Psyllium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Daytime Cold and Cough and NightTime Cold and Congestion Childrens Brompheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl, Phenylephrine HCl NDC 11673-0059 |
Kit | TARGET Corporation | OTC |
- Recalling firm
- Raritan Pharmaceuticals, Inc.
- NDC code
- 11673-059-87
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-025-2013 · 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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