Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80389

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

Open FDA event record

Event summary

Timeline bucket
June 25, 2018
Product types
Drug
Classifications
Class III
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

Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]

D-0915-2018
Recall number
D-0915-2018
Initiated
June 25, 2018
Classification
Class III
Status
Terminated
Recalling firm
AMERICAN HEALTH PACKAGING
Quantity
1285 cartons (cartons of 100 individual unit doses)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant

Code information

Lot# 166023 - Exp. 11/30/18 (232 units). Lot# 168467 - Exp. 2/28/19 (1053 units).

Distribution pattern

Lot#166023 products distributed from 12/29/16 to 1/19/17 and Lot#168467 distributed from 4/6/17 to 9/11/17. Distributors are the wholesalers who received the product; others are the Corporate Offices for those wholesalers.