ONDANSETRON HYDROCHLORIDE

Generic: ONDANSETRON HYDROCHLORIDE

Ipca Laboratories LimitedManufacturer

ORALRoute

ONDANSETRON HYDROCHLORIDEActive Substance

2014-01-23Original Approval

ONDANSETRON HYDROCHLORIDE is FDA application ANDA203761, sponsored by IPCA LABS LTD. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2013-05-20

Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira

Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles foun

Class II2025-12-30

Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Ma

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, tha

Class II2013-09-24

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 6

Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were

Class II2012-09-27

ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceutica

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Class III2019-05-22

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 6332

Failed Impurities/Degradation Specifications.

Class II2022-04-13

Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30

cGMP deviations: Temperature abuse

Class II2023-11-14

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation

ONDANSETRON HYDROCHLORIDE

Recalls

Top Reported Reactions