Why it was recalled
Failed dissolution specifications.
Product description
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
Lot numbers, UPCs & expiration codes
Lot #: IB220023A, exp. date 08/2022
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1293-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 18, 2022
- FDA report date
- Aug 3, 2022
- Quantity
- 9,600 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1293-2022, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 90610
- Address
- 207 Kiley Dr
- Code information
- Lot #: IB220023A, exp. date 08/2022
- Postal code
- 21801-2249
- Report date
- Aug 3, 2022
- Product type
- Drugs
- Recall number
- D-1293-2022
- Classification
- Class II
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 9,600 bottles
- Termination date
- Nov 22, 2022
- Reason for recall
- Failed dissolution specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 18, 2022
- Initial firm notification
- Letter
- Center classification date
- Jul 26, 2022