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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73569

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 29, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Allegiant Health

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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
Recall number
D-0856-2016
Initiated
February 29, 2016
Classification
Class III
Status
Terminated
Recalling firm
Allegiant Health
Quantity
a) 9816 bottles; b) 9648 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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