Exact FDA event identifier

Event 80386

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

Event summary

Timeline bucket: July 24, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Morton Grove Pharmaceuticals, 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

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

Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.

D-1042-2018

Recall number: D-1042-2018
Initiated: July 24, 2018
Classification: Class II
Status: Terminated
Recalling firm: Morton Grove Pharmaceuticals, Inc.
Quantity: 38,280 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Container: Tamper Evident foil seal not completely intact.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Tamper Evident foil seal not completely intact.

Code information

Lot US1259

Distribution pattern

U.S. Nationwide