Equate Fiber Therapy Recalled for Possible C. Difficile Contamination
Raritan Pharmaceuticals is recalling Equate Fiber Therapy 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 associated with significant health risks, meeting the criteria for a Severe rating.
Plain-English summary
Raritan Pharmaceuticals, Inc. is recalling Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, 160 capsules per bottle. The product is distributed by Wal-Mart Stores, Inc. and is identified by NDC 68163-119-60 and UPC 6-81131-77922-7.
The recall is being conducted due to possible microbial contamination by C. difficile discovered in the raw material. The affected lots are 15952, 16271, 16274, 16425 (Exp 06/15) and 16434, 16435, 16436, 16459, 16461, 16462, 16465 (Exp 07/15). A total of 183,141 bottles were distributed nationwide.
Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and return it to the place of purchase or contact the recalling firm for instructions.
The recalled product
- Product
- Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 68163-119-60, UPC 6-81131-77922-7.
- Manufacturer
- Raritan Pharmaceuticals, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 183,141
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 (14)
- Item Number: 4091097
- Lots 15952
- 16271
- 16274
- 16425
- Exp 06/15
- 16434
- 16435
- 16436
- 16459
- 16461
- 16462
- 16465
- 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
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