Recalls / Class II
Class IID-1294-2022
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
- Brand name
- Irbesartan
- Generic name
- Irbesartan
- Active ingredient
- Irbesartan
- Route
- Oral
- NDCs
- 59746-447, 59746-448, 59746-449
- FDA application
- ANDA203534
- Affected lot / code info
- Lot #: IB120012A, IB120013A, IB120014A Exp. date 08/2022
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Manufacturer
- Jubilant Cadista Pharmacuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 28,560 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-07-18
- FDA classified
- 2022-07-26
- Posted by FDA
- 2022-08-03
- Terminated
- 2022-11-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1294-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.