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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75278

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

Open FDA event record

Event summary

Timeline bucket
September 09, 2016
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cadila Pharmaceuticals Limited

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

Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002

D-0164-2017
Recall number
D-0164-2017
Initiated
September 09, 2016
Classification
Class II
Status
Terminated
Quantity
6.0kg

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Product

Code information

Supplied Batch, 150N004; Exp. 08/20 Supplied Batch, 150N006; Exp. 09/20

Distribution pattern

According to the firm, the API distributed to two consignees in the US. See Consignee list below. Consignee List: 1). LLC LENS Phanna. Russia 2). Claris irljectable, Ahmedabad 3). CPL. Inc, USA