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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75083

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

Open FDA event record

Event summary

Timeline bucket
August 18, 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 - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,

D-1515-2016
Recall number
D-1515-2016
Initiated
August 18, 2016
Classification
Class III
Status
Terminated
Quantity
32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)

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- bottles missing colored coded panel where strength of the product is displayed.

Code information

Lot #: AS1413A, AS1414A; Exp. 11/18

Distribution pattern

Nationwide