Drug recall D-0856-2016

Class III Terminated reported May 25, 2016

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.

Lots and codes

Lot #: 5C344105, Exp 02/17

Recall details

Recalling firm
Allegiant Health, Deer Park, NY
Quantity
a) 9816 bottles; b) 9648 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
February 29, 2016
Terminated
June 6, 2018