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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70857

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

Open FDA event record

Event summary

Timeline bucket
March 26, 2015
Product types
Drug
Classifications
Class III
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

Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20

D-1083-2015
Recall number
D-1083-2015
Initiated
March 26, 2015
Classification
Class III
Status
Terminated
Quantity
1,363 UD Cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing

Code information

Lot #: 3051728, 3053762, Exp. 4/2015

Distribution pattern

Nationwide