Recall: D-1294-2022

Class II - Potentially Harmful

Class IIClassification

2022-07-18Initiated

TerminatedStatus

Jubilant Cadista PharmaceuticaFirm

Product

Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90

Reason

Failed Dissolution Specifications

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.