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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85386

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

Open FDA event record

Event summary

Timeline bucket
April 15, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Amneal Pharmaceuticals of New York, LLC

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

Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15

D-1253-2020
Recall number
D-1253-2020
Initiated
April 15, 2020
Classification
Class II
Status
Terminated
Quantity
11258 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Code information

06598004A 04/2020 06599001A 12/2020 06599002A 12/2020

Distribution pattern

Nationwide