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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94924

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

Open FDA event record

Event summary

Timeline bucket
July 02, 2024
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Novel Laboratories, Inc. d.b.a 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

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.

D-0628-2024
Recall number
D-0628-2024
Initiated
July 02, 2024
Classification
Class III
Status
Terminated
Quantity
13,200 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective container: potential for non-sealed pouches which can lead to product leakage.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective container: potential for non-sealed pouches which can lead to product leakage.

Code information

Lot #S300542, exp. date June 30, 2025

Distribution pattern

Nationwide in the US.