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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84931

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

Open FDA event record

Event summary

Timeline bucket
December 23, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GSK Consumer Health, 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

Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03

D-0996-2020
Recall number
D-0996-2020
Initiated
December 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
GSK Consumer Health, Inc
Quantity
431,614 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.

Code information

Lot: K79A, K79B, K79C, exp 3/31/2021; XB2W, Y23L, Y23V, exp 5/31/2021; 19N1793000, 19N1895942, 19N1952247, 19N1884668, 19N1936498, 19N1936583, exp 3/31/2021; 19N1920630, 19N1958240, exp 4/30/2021; 19N1957675, M926001MA, M926002MA, M926003MA, M926004MA, M926005MA, M926006MA, M926007MA, M926008MA, M926009MA, M926201MA, M926202MA, exp 5/31/2021; M926201MB, M926202MB, M926203MB, M926204MB, M926205MB, M926206MB, M926207MB, M926208MB, M926209MB, exp 2/28/2021

Distribution pattern

Distributed Nationwide in the USA