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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
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