D-0856-2016 Class III Terminated
FDA drug recall D-0856-2016 was initiated by Allegiant Health on Feb 29, 2016 and is designated Class III. Reason for recall: Superpotent Drug: High out of specification results for assay at the 6 month time point interval. The recall status is terminated (terminated Jun 6, 2018). Affected quantity: a) 9816 bottles; b) 9648 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- May 25, 2016
- Initiation Date
- Feb 29, 2016
- Termination Date
- Jun 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 9816 bottles; b) 9648 bottles
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.
Distribution pattern
Nationwide
Code information
Lot #: 5C344105, Exp 02/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0856-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026