Raritan Pharmaceuticals Recalls DRxChoice Fiber Capsules Due to Microbial Contamination
Raritan Pharmaceuticals is recalling DRxChoice 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 FDA classified this as a Class II recall involving 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.
Plain-English summary
Raritan Pharmaceuticals, Inc. is recalling DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber. The recall involves 17,136 bottles distributed nationwide. The affected lots are 16274 (Exp 06/15) and 16471 (Exp 08/15).
The product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. The FDA has classified this as a Class II recall.
Consumers who have purchased these specific lots should stop using the product and contact Raritan Pharmaceuticals for further instructions.
The recalled product
- Product
- DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1.
- Manufacturer
- Raritan Pharmaceuticals, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 17,136
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 (3)
- Lots: 16274
- Exp 06/15
- 16471 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.
See all 12 products in this recall →Related recalls
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