Raritan Pharmaceuticals Recalls Fiber Capsules Due to Microbial Contamination
Raritan Pharmaceuticals is recalling Berkley & Jensen 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, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Raritan Pharmaceuticals, Inc. is recalling 3,552 bottles of Berkley & Jensen Fiber Capsules, a fiber laxative and supplement containing 100% natural psyllium fiber. The product is identified by Lot 16470 and an expiration date of 08/15. The recall is being conducted due to possible microbial contamination by C. difficile discovered in the raw material used to manufacture the product.
The affected product was distributed nationwide. Consumers who have purchased this specific lot of fiber capsules should stop using the product and return it to the place of purchase or contact the recalling firm for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC 4-00016-27053-2.
- Manufacturer
- Raritan Pharmaceuticals, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 3,552
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 (2)
- Lot 16470
- Exp 08/15
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.
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