Exact FDA event identifier

Event 77798

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

Event summary

Timeline bucket: June 15, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Tris Pharma 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

Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01

D-1126-2017

Recall number: D-1126-2017
Initiated: June 15, 2017
Classification: Class II
Status: Terminated
Recalling firm: Tris Pharma Inc.
Quantity: 34,824 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective container: Oral solution leaking from container.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective container: Oral solution leaking from container.

Code information

Lot #: 08215001A, Exp 6/30/2017; 08215002A, 08215004A, Exp 7/31/2017

Distribution pattern

U.S.A. Nationwide