PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: May 25, 2016 Initiated: February 29, 2016 #D-0856-2016

Product Description

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.

Details

Recalling Firm
Allegiant Health
Units Affected
a) 9816 bottles; b) 9648 bottles
Distribution
Nationwide
Location
Deer Park, NY

Frequently Asked Questions

What product 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.. Recalled by Allegiant Health. Units affected: a) 9816 bottles; b) 9648 bottles.
Why was this product recalled?
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 25, 2016. Severity: Low. Recall number: D-0856-2016.