Raritan Recalls Leader Fiber Capsules Due to C. Difficile Contamination
Raritan Pharmaceuticals is recalling Leader Fiber Capsules due to possible C. difficile contamination found in raw materials.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 2,988 bottles of Leader Fiber Capsules, a 100% natural psyllium fiber laxative and dietary fiber supplement. The product is distributed by Cardinal Health in Dublin, Ohio, and was sold nationwide.
The recall is being conducted because of possible microbial contamination by C. difficile, which was discovered in the raw material used to manufacture the product. The affected units are identified by CIN 3510963, Lots 16273 and 16274, and an expiration date of 06/15.
Consumers who have purchased these specific bottles should stop using the product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Raritan Pharmaceuticals, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 2,988
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 (4)
- CIN 3510963
- Lots 16273
- 16274
- Exp 06/15
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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