Raritan Recalls Fiber Capsules Due to Possible C. Difficile Contamination
Raritan Pharmaceuticals is recalling Simply Right Healthcare Fiber Capsules due to possible C. difficile contamination found in raw materials.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves C. difficile, a high-risk pathogen. Per the rubric, FDA Class II recalls involving significant pathogens or potential for serious injury are rated as Severe (4).
Plain-English summary
Raritan Pharmaceuticals, Inc. is recalling Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, 400 capsules per bottle. The product is distributed by SAM'S West, Inc., in Bentonville, Arkansas, and carries UPC 0-78742-00524-9.
The recall is being conducted because of possible microbial contamination by C. difficile discovered in the raw material used to manufacture the product. The affected lots are 16273 (Exp 06/15), 16460, 16464, 16466, 16468, and 16469 (Exp 07/15). A total of 46,104 bottles were distributed nationwide.
Consumers who have purchased these specific lots should stop using the product and contact the distributor or retailer for a refund or replacement. The FDA has classified this recall as Class II, indicating a situation in which there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for Regularity, 400 capsules per bottle, Distributed by: SAM'S West, Inc., Bentonville, AR 72716, UPC 0-78742-00524-9.
- Manufacturer
- Raritan Pharmaceuticals, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 46,104
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 (8)
- Lots 16273
- Exp 06/15
- 16460
- 16464
- 16466
- 16468
- 16469
- Exp 07/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Raritan Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Raritan Pharmaceuticals, Inc.
See all →- ModerateRaritan Recalls Kids' Relief Ear Liquid Due to Manufacturing Deviations
FDA (Drugs) · 2017-01-04
- ModerateCVS Health Homeopathic Infants Teething Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2017-01-04
- ModerateRaritan Recalls CVS Kids' Ear Relief Liquid for Manufacturing Deviations
FDA (Drugs) · 2017-01-04
- SevereEquate Fiber Therapy Recalled for Possible C. Difficile Contamination
FDA (Drugs) · 2012-10-31
- SevereRaritan Recalls Leader Fiber Capsules Due to C. Difficile Contamination
FDA (Drugs) · 2012-10-31
Same hazard · c difficile
See all →- HighSterling Gelatin Recalls Limed Bone Gelatin Due to C. Difficile Contamination
FDA (Drugs) · 2012-11-28
- SevereRaritan Pharmaceuticals Recalls Wal-Mucil Fiber Laxative Due to Microbial Contamination
FDA (Drugs) · 2012-10-31
- SevereRaritan Recalls Up&Up Psyllium Fiber Supplement for C. Difficile Contamination
FDA (Drugs) · 2012-10-31
- SevereRaritan Pharmaceuticals Recalls Premier Value Fiber Capsules Due to C. Difficile Contamination
FDA (Drugs) · 2012-10-31
- SevereCVS Pharmacy Fiber Capsules Recalled for Possible C. Difficile Contamination
FDA (Drugs) · 2012-10-31