Class II · Moderate risk
Irbesartan Tablets USP
Out of Specification for Dissolution
Westminster Irbesartan Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Cause type: Nitrosamine impurity
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls. All nitrosamine impurity recalls.
What was recalled
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
Affected NDCs
69367-0121-01
69367-0121-03
Compare with the code on your package — it is the most precise check available.
Drug: Irbesartan Category: Blood Pressure Medication
- Recalling firm
- Westminster Pharmaceuticals Llc
- NDC code
- 69367-121-01
- Origin
- MS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0302-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Irbesartan recalls
See all
Class II · Moderate risk
Irbesartan Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Irbesartan Tablets
Failed dissolution specifications.
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Other recalls by Westminster Pharmaceuticals Llc
All 2018 recalls
Class II · Moderate risk
Metoprolol Tartrate Tablets
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II · Moderate risk
Metoprolol Tartrate Tablets
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II · Moderate risk
Westminster Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk
Westminster Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
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