Exact FDA event identifier

Event 87650

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

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Event summary

Timeline bucket: March 31, 2021
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 (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631-206-02.

D-0334-2021

Recall number: D-0334-2021
Initiated: March 31, 2021
Classification: Class II
Status: Terminated
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Quantity: 13,834 bottles

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 Product

Code information

Lot #: J190386A, X190354A, Exp. 3/2021, J190393A, Exp. 5/2021, A200035A, Exp. 6/2021, B200064A, Exp. 8/2021; H200236A, Exp. 1/2022

Distribution pattern

Nationwide within the United States