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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65495

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

Open FDA event record

Event summary

Timeline bucket
May 21, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
American Health Packaging

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

Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01

D-856-2013
Recall number
D-856-2013
Initiated
May 21, 2013
Classification
Class II
Status
Terminated
Recalling firm
American Health Packaging
Quantity
48.230 carton units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Mispackaging

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.

Code information

Lot #: 114215, Exp 7/13; 114216, Exp 7/13; 114217, Exp 7/13; 120087, Exp 9/13; 120295, Exp 9/13; 121573, Exp 6/14; 123572, Exp 9/14; 123983, Exp 9/14; 130071, Exp 2/15

Distribution pattern

Nationwide.