Exact FDA event identifier

Event 89814

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

Event summary

Timeline bucket: March 11, 2022
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: DASH Pharmaceuticals 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458.

D-0749-2022

Recall number: D-0749-2022
Initiated: March 11, 2022
Classification: Class II
Status: Terminated
Recalling firm: DASH Pharmaceuticals LLC
Quantity: 45,940 Unit Dose Cups

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Mix-Up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix-Up

Code information

Lot #: a) 376908P40, Exp. Date 02/28/2023; b) 376908P100, Exp. Date 02/28/2023

Distribution pattern

Nationwide within the United States