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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82298

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

Open FDA event record

Event summary

Timeline bucket
March 05, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Johnson Matthey 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 USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742

D-1077-2019
Recall number
D-1077-2019
Initiated
March 05, 2018
Classification
Class II
Status
Terminated
Recalling firm
Johnson Matthey Inc.
Quantity
169.976 kg

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination
Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.

Code information

Lot# B1414-160809, Retest Date AUG 2021

Distribution pattern

Nationwide in the US