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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77567

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

Open FDA event record

Event summary

Timeline bucket
June 16, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Sandoz Incorporated

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

Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540

D-0943-2017
Recall number
D-0943-2017
Initiated
June 16, 2017
Classification
Class III
Status
Terminated
Recalling firm
Sandoz Incorporated
Quantity
38,234 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination With Other Product: Imipramine

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination With Other Product: Imipramine

Code information

Lot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.

Distribution pattern

Product was distributed throughout the United States