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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70840

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

Open FDA event record

Event summary

Timeline bucket
November 10, 2014
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Reckitt Benckiser LLC

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

Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OTC, Distributed by Reckitt Benckiser, Parsippany, NJ 07054-0224 Made in England

D-0964-2015
Recall number
D-0964-2015
Initiated
November 10, 2014
Classification
Class III
Status
Terminated
Recalling firm
Reckitt Benckiser LLC
Quantity
155 cases (2000 pouches of 2 tablets per case)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
defective seal

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch

Code information

Lot BD375 exp 06/2016; BD566, BD661 exp. 08/2016

Distribution pattern

Nationwide