Drug 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.
D-0856-2016
Product summary
- Firm
- Allegiant Health
- Event
- Event 73569
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 9816 bottles; b) 9648 bottles
- Official record key
drug-enforcement:D-0856-2016
Official wording
Reason: Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Code information: Lot #: 5C344105, Exp 02/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent