Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75604

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

Open FDA event record

Event summary

Timeline bucket
November 04, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
West-Ward Pharmaceuticals Corp.

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

Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01

D-0147-2017
Recall number
D-0147-2017
Initiated
November 04, 2016
Classification
Class III
Status
Terminated
Quantity
32,102 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Label Error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.

Code information

Lot #: AS1466A, Exp. Jan 2019

Distribution pattern

Nationwide