Exact FDA event identifier

Event 85861

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

Open FDA event record

Event summary

Timeline bucket: June 12, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: The Harvard Drug Group

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 Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61

D-1360-2020

Recall number: D-1360-2020
Initiated: June 12, 2020
Classification: Class II
Status: Terminated
Recalling firm: The Harvard Drug Group
Quantity: 1,906 Cartons

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 Deviation

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.

Code information

Lot T-02134, exp 09/2020

Distribution pattern

Nationwide USA