Exact FDA event identifier

Event 86464

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

Open FDA event record

Event summary

Timeline bucket: September 23, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: SUN PHARMACEUTICAL INDUSTRIES 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

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

RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17

D-0002-2021

Recall number: D-0002-2021
Initiated: September 23, 2020
Classification: Class II
Status: Terminated
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Quantity: 747 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

NDMA) impurity

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: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.

Code information

Lot #: AB06381; Exp 10/2021

Distribution pattern

Nationwide