Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, Indi
Summary
The FDA issued a Class II for Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubi by Jubilant Cadista Pharmaceuticals, Inc.. Reason: Failed Dissolution Specifications.
Details
Source
Drug Recall
External ID
D-1294-2022
Action Date
2022-08-03
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: IB120012A, IB120013A, IB120014A Exp. date 08/2022
Quantity Affected: 28,560 bottles
Reason for Recall
Failed Dissolution Specifications
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-18
Company
Salisbury, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 77 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Jubilant Cadista Pharmaceuticals, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jubilant Cadista Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jubilant Cadista Pharmaceuticals, Inc. have FDA actions?
Jubilant Cadista Pharmaceuticals, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1294-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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