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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81908

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

Open FDA event record

Event summary

Timeline bucket
January 09, 2019
Product types
Drug
Classifications
Class II
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

Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01

D-0423-2019
Recall number
D-0423-2019
Initiated
January 09, 2019
Classification
Class II
Status
Terminated
Quantity
14,400 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
extraneous material
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; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.

Code information

lot F801282, Expiry June 2020

Distribution pattern

Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States.