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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82528

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

Open FDA event record

Event summary

Timeline bucket
April 01, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Lupin 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

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06

D-1121-2019
Recall number
D-1121-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
12,504 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications; 18 month long term stability study.

Code information

G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019

Distribution pattern

Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.