FDA-Drug2016-05-25Class III
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.
Allegiant Health
Hazard
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Sold states
Nationwide
Affected count
a) 9816 bottles; b) 9648 bottles
Manufactured in
75 N Industry Ct, N/A, Deer Park, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0856-2016Don't want to check this manually?
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