Exact FDA event identifier

Event 76038

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

Event summary

Timeline bucket: December 21, 2016
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Teva Pharmaceuticals USA

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73

D-0440-2017

Recall number: D-0440-2017
Initiated: December 21, 2016
Classification: Class II
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA
Quantity: 133,601 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotency

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotency: due to a low, out of specification test result for assay during stability testing.

Code information

Lot # 35432507A, 35434914A, 35435798A, 35437490A, Exp 9/19

Distribution pattern

United States and Puerto Rico