col-rite — Class III drug recall D-0856-2016
Terminated recall by Allegiant Health, reported 2016-05-25, distributed nationwide. Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
| Recall number | D-0856-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allegiant Health, Deer Park, NY, United States |
| Recall initiated | 2016-02-29 |
| Classified | 2016-05-17 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2018-06-06 |
| Distributed | Nationwide (US) |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 00011822511049, 00011822573924 |
| Lot numbers | 02/17, 5C344105 |
| Model numbers | 351104, 357392 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0856-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.