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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66169

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

Open FDA event record

Event summary

Timeline bucket
August 30, 2013
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Watson Laboratories Inc

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

Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05.

D-1061-2013
Recall number
D-1061-2013
Initiated
August 30, 2013
Classification
Class III
Status
Terminated
Recalling firm
Watson Laboratories Inc
Quantity
875 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.

Code information

Lot 706224A and 706225A, Exp. 04/15.

Distribution pattern

Nationwide