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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80133

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

Open FDA event record

Event summary

Timeline bucket
May 25, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Jubilant Cadista 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

Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90

D-0876-2018
Recall number
D-0876-2018
Initiated
May 25, 2018
Classification
Class III
Status
Terminated
Quantity
2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).

Code information

Lot #: VR417065A, VR417066A, Exp 10/2019

Distribution pattern

IN, MI, MS, NC, NJ, NY and OH