Exact FDA event identifier

Event 63899

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

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Event summary

Timeline bucket: December 14, 2012
Product types: Drug
Classifications: Class I
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

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

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by &amp; Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.

D-166-2013

Recall number: D-166-2013
Initiated: December 14, 2012
Classification: Class I
Status: Terminated
Recalling firm: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Quantity: 3,407 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.

Code information

Lot #: 3037841, 3040859, 3042573, Exp 12/13

Distribution pattern

Nationwide