Allegiant Health recalls col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; a…

Recall date

February 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0856-2016

FDA classification

Class III

Brand / firm

Allegiant Health

Sold / distributed

Nationwide

Why it was recalled

Superpotent Drug: High out of specification results for assay at the 6 month time point interval.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.