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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88033

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

Open FDA event record

Event summary

Timeline bucket
June 01, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
VIONA PHARMACEUTICALS 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

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

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01

D-0640-2021
Recall number
D-0640-2021
Initiated
June 01, 2021
Classification
Class II
Status
Terminated
Recalling firm
VIONA PHARMACEUTICALS INC
Quantity
21240 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: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Code information

Lot M915601 & M915602, Oct 2021

Distribution pattern

Nationwide in the US