Konsyl Psyllium Fiber Recalled for Inaccurate Labeling of Active Ingredient Strength
Konsyl Pharmaceuticals is recalling 6,286 bottles of Psyllium Fiber capsules because the label lists an inaccurate strength for the active ingredient.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition indicates the product is not likely to cause adverse health consequences. The hazard is limited to a labeling error regarding strength.
Plain-English summary
Konsyl Pharmaceuticals, Inc. is recalling 6,286 bottles of PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC (NDC: 0224-1847-10). The recall was initiated due to a labeling error where the listed active ingredient strength is inaccurate.
The affected product was distributed in the United States, including Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, South Carolina, and Puerto Rico, as well as in the Dominican Republic. The specific lot numbers involved are A44701, A44701C, and J34701C-1, all with an expiration date of 07/16.
Consumers who have purchased this product should check their bottles for the affected lot numbers and expiration dates. If the product matches the description, consumers should stop using it and contact Konsyl Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.
- Manufacturer
- Konsyl Pharmaceuticals Inc
- Category
- Drug — OTC Supplement
- Hazard
- Affected units
- 6,286
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)
- Lot #: A44701 (expiry: 07/16)
- A44701C (expiry: 07/16)
- J34701C-1 (expiry: 07/16)
Distribution
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