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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80782

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 07, 2018
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

Complete imported group

Every recalled product in this event

2 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 2

Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01

D-1186-2018
Recall number
D-1186-2018
Initiated
August 07, 2018
Classification
Class III
Status
Terminated
Quantity
11,799 bottles of 100

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: Out of specification test results obtained during routine stability testing for related compound.

Code information

Batch code # 3093163, expiration date 04/2019

Distribution pattern

Distributed Nationwide in the US

drug · product 2 of 2

Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05

D-1187-2018
Recall number
D-1187-2018
Initiated
August 07, 2018
Classification
Class III
Status
Terminated
Quantity
656 500-count 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: Out of specification test results obtained during routine stability testing for related compound.

Code information

Batch code # 3093163, expiration date 04/2019

Distribution pattern

Distributed Nationwide in the US