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.

FDA recall notice · announced May 25, 2016 · Allegiant Health

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lot #: 5C344105, Exp 02/17
Quantity: a) 9816 bottles; b) 9648 bottles
Status: Terminated
Products in this recall event:
- 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 HU (D-0856-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.