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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85745

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

Open FDA event record

Event summary

Timeline bucket
May 19, 2020
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

Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11

D-1293-2020
Recall number
D-1293-2020
Initiated
May 19, 2020
Classification
Class II
Status
Terminated
Recalling firm
American Health Packaging
Quantity
15,755 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed dissolution specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).

Code information

Lots 179605, Exp 06/30/2020; 181105, Exp 08/31/2020; 183019, Exp 01/31/2021

Distribution pattern

USA Nationwide