The Recall Desk
SevereFDA (Drugs)·D-0164-2017·Announced 2016-12-07

Cadila Pharmaceuticals Recalls Microbially Contaminated Ondansetron HCI API

Cadila Pharmaceuticals is recalling bulk Ondansetron HCI API due to microbial contamination. The affected product was distributed to two US consignees.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the hazard of microbial contamination in a pharmaceutical API.

Plain-English summary

Cadila Pharmaceuticals Limited is recalling bulk Ondansetron HCI API due to microbial contamination of a non-sterile product. The recalled product consists of 6.0kg of API supplied in batches 150N004 (exp. 08/20) and 150N006 (exp. 09/20).

According to the firm, the API was distributed to two consignees in the US: LLC LENS Phanna and CPL. Inc. The source text also lists Claris Injectable in Ahmedabad as a consignee, though the distribution pattern specifically notes two US consignees.

This recall is classified as FDA Class II. Consumers and healthcare providers should stop using the affected product and contact the manufacturer for further instructions.

The recalled product

Product
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
Manufacturer
Cadila Pharmaceuticals Limited
Category
Drug — Pharmaceutical API
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Supplied Batch
  • 150N004
  • Exp. 08/20 Supplied Batch
  • 150N006
  • Exp. 09/20

Distribution

Distribution scope not specified by the agency.

Related recalls

Same hazard · microbial contamination

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