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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73848

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

Open FDA event record

Event summary

Timeline bucket
April 04, 2016
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

Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30

D-1052-2016
Recall number
D-1052-2016
Initiated
April 04, 2016
Classification
Class III
Status
Terminated
Quantity
59,520 Bottles

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.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Code information

Lot #: a) H303459, b) H303460, Exp 09/2016

Distribution pattern

Nationwide and Puerto Rico