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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76463

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

Open FDA event record

Event summary

Timeline bucket
January 27, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

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

Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20

D-0493-2017
Recall number
D-0493-2017
Initiated
January 27, 2017
Classification
Class II
Status
Terminated
Quantity
58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Tablets

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled

Code information

Batch #3083289; Exp. Date 12/2018

Distribution pattern

Nationwide