FDA recall D-0856-2016

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-02-29

Report date

2016-05-25

Termination date

2018-06-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deer Park, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0856-2016