Raritan Pharmaceuticals Recalls Wal-Mucil Fiber Laxative Due to Microbial Contamination
Raritan Pharmaceuticals is recalling specific lots of Wal-Mucil fiber laxative capsules due to possible C. difficile contamination in the raw material.
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 agency classification is FDA Class II, and the source identifies C. difficile, a high-risk pathogen, as the cause of the contamination, meeting the criteria for a Severe rating.
Plain-English summary
Raritan Pharmaceuticals, Inc. is recalling specific lots of Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement. The affected products include 160-capsule bottles (Item #503663) and 320-capsule bottles (Item #586143) distributed by Walgreen Co. The recall involves 56,808 bottles distributed nationwide.
The recall is being conducted due to possible microbial contamination by C. difficile discovered in the raw material. The affected lots are 15952, 16270, and 16425 (Expiration 06/15) for the 160-capsule bottles, and 16459, 16466, and 16467 (Expiration 07/15) for the 320-capsule bottles.
Consumers should check their inventory for these specific lot numbers and expiration dates. If they have these products, they should stop using them and contact the recalling firm or retailer for instructions on return or disposal.
The recalled product
- Product
- Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement, a)160 capsules per bottle (item #503663), and b) 320 capsules per bottle (Item #586143), Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616, www.walgreens.com, a) UPC…
- Manufacturer
- Raritan Pharmaceuticals, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 56,808
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 a) 15952
- 16270
- 16425
- Exp 06/15
- b)16459
- 16466
- 16467
- 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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