Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Product description
Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03
Lot numbers, UPCs & expiration codes
Batch Numbers: a) B162008A Exp. 09/30/2019, C162002A Exp. 02/29/2020; b) B162008B Exp. 09/30/2019, C162002B Exp. 02/29/2020
Where it was sold
Nationwide.
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-0302-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 29, 2018
- FDA report date
- Dec 19, 2018
- Quantity
- 3976 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Westminster Pharmaceuticals Llc
Original FDA data
Every field from FDA enforcement report D-0302-2019, exactly as published.
Show all FDA fields
- City
- Olive Branch
- State
- MS
- Status
- Terminated
- Country
- United States
- Event ID
- 81668
- Address
- 1 & 2
- Address (line 2)
- 154 Downing Street
- Code information
- Batch Numbers: a) B162008A Exp. 09/30/2019, C162002A Exp. 02/29/2020; b) B162008B Exp. 09/30/2019, C162002B Exp. 02/29/2020
- Postal code
- 38654
- Report date
- Dec 19, 2018
- Product type
- Drugs
- Recall number
- D-0302-2019
- Classification
- Class II
- Recalling firm
- Westminster Pharmaceuticals Llc
- Product quantity
- 3976 bottles
- Termination date
- Oct 26, 2021
- Reason for recall
- CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03
- Distribution pattern
- Nationwide.
- Recall initiation date
- Oct 29, 2018
- Initial firm notification
- Letter
- Center classification date
- Dec 14, 2018