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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80266

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

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Event summary

Timeline bucket
June 13, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
LUPIN SOMERSET

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

Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716

D-0907-2018
Recall number
D-0907-2018
Initiated
June 13, 2018
Classification
Class III
Status
Terminated
Recalling firm
LUPIN SOMERSET
Quantity
2,229,052 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.

Code information

a) M16425A, Exp 06/18; M16463A, Exp 7/18; M16516A, Exp 8/19; M16605A, Exp 10/19; M17005A, Exp 1/20; S700119, S700157, Exp 3/20; S700228, Exp 4/20; S700304, Exp 5/20; S700510, Exp 7/20; S700780, Exp 10/20; S701063, S701112, Exp 12/20; S800170, Exp 2/21; S800349, Exp 3/21; S800366, Exp 4/21; S800453, Exp 5/21; b) M16560A, M16561A, M16562A, Exp 9/19; M16607A, Exp 11/19; S700202, Exp 4/20; S700415, Exp 6/20; S700511, Exp 7/20; S700752, Exp 9/20; S700902, Exp 10/20; S701119, Exp 12/20; S800097, Exp 2/21; S800296, S800306, Exp 3/21.

Distribution pattern

Nationwide