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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77798

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

Open FDA event record

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

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