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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70503

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

Open FDA event record

Event summary

Timeline bucket
February 13, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Qualitest Pharmaceuticals

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

AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

D-0397-2015
Recall number
D-0397-2015
Initiated
February 13, 2015
Classification
Class II
Status
Terminated
Recalling firm
Qualitest Pharmaceuticals
Quantity
2808 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed tablet specifications: One lot was found to contain oversized tablets.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed tablet specifications: One lot was found to contain oversized tablets.

Code information

Lot T018H14A, Exp 08/16

Distribution pattern

Nationwide