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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65676

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

Open FDA event record

Event summary

Timeline bucket
July 15, 2013
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Braintree Laboratories Inc.

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

Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02

D-911-2013
Recall number
D-911-2013
Initiated
July 15, 2013
Classification
Class III
Status
Terminated
Quantity
10,362 kit cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder

Code information

Lot 3013002 Exp. 08/14

Distribution pattern

Nationwie

Field note

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