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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80364

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 24, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
West-Ward Columbus 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

2 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 2

Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.

D-1024-2018
Recall number
D-1024-2018
Initiated
July 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
West-Ward Columbus Inc
Quantity
29,048 bottles (1,452,400 tablets)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications:

Code information

Lot# 71545B, Expiry date: 01/19

Distribution pattern

Nationwide in the USA.

drug · product 2 of 2

Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.

D-1025-2018
Recall number
D-1025-2018
Initiated
July 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
West-Ward Columbus Inc
Quantity
29048 500-count bottles (14,524,000 tablets)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications:

Code information

Lot# 71545A, Expiry date: 07/19

Distribution pattern

Nationwide in the USA.