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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62454

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

Open FDA event record

Event summary

Timeline bucket
June 29, 2012
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mylan LLC.

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

Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01

D-066-2013
Recall number
D-066-2013
Initiated
June 29, 2012
Classification
Class II
Status
Terminated
Recalling firm
Mylan LLC.
Quantity
15181 bottles.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed USP Content Uniformity Requirements: OOS result reported on retained samples.

Code information

Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12

Distribution pattern

Natiowide