Exact FDA event identifier

Event 86696

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

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Event summary

Timeline bucket: November 01, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Preferred 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

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

Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.

D-0077-2021

Recall number: D-0077-2021
Initiated: November 01, 2020
Classification: Class II
Status: Terminated
Recalling firm: Preferred Pharmaceuticals, Inc.
Quantity: 99 bottles (9990 Extended Release Tablets)

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.

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Reason for recall

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Code information

E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022

Distribution pattern

Distributed to two physician's offices located in FL.