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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81099

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

Open FDA event record

Event summary

Timeline bucket
October 03, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
InvaGen 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

Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15

D-0012-2019
Recall number
D-0012-2019
Initiated
October 03, 2018
Classification
Class III
Status
Terminated
Quantity
2880 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.

Code information

Lot #: GG80218, Exp. 12/2019

Distribution pattern

Nationwide with the United States