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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78217

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

Open FDA event record

Event summary

Timeline bucket
April 18, 2017
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

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 (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512

D-0109-2018
Recall number
D-0109-2018
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products

Code information

A lot # 160031A, A160031B; Exp. 11/17

Distribution pattern

Nationwide