Allegiant Health Recalls Col-Rite Stool Softeners for Potency Issues
Allegiant Health is recalling specific lots of Col-Rite stool softeners because they failed potency tests. Consumers should stop using the product and return it to the pharmacy.
What this means for you
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Allegiant Health is voluntarily recalling specific lots of Col-Rite (docusate sodium) stool softener softgels, 50 mg. The recall involves 30-count and 60-count bottles distributed by Rite Aid. The affected product is identified by Lot # 5C344105 with an expiration date of 02/17.
The recall was initiated because the product produced high out-of-specification results for assay at the 6-month time point interval. This indicates that the medication may not contain the correct amount of the active ingredient as labeled.
The recall is classified as Class III by the FDA, which means the product is unlikely to cause adverse health consequences. Consumers who have this specific lot of Col-Rite should stop using it and return it to the pharmacy or store where it was purchased for a refund.
The recalled product
- Product
- col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
- Manufacturer
- Allegiant Health
- Category
- Drug — Stool Softener
- Hazard
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 (2)
- Lot #: 5C344105
- Exp 02/17
Distribution
Distributed nationwide across the United States.
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