Exact FDA event identifier

Event 82086

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

Event summary

Timeline bucket: February 13, 2019
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Mylan 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

Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505

D-0506-2019

Recall number: D-0506-2019
Initiated: February 13, 2019
Classification: Class III
Status: Terminated
Recalling firm: Mylan Pharmaceuticals Inc.
Quantity: 8,159 bottles

App-derived interpretation

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

Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing

Code information

Lot #: 3090167, Exp. October 2019

Distribution pattern

Throughout the United States