Class II · Moderate risk
Irbesartan Tablets USP
Out of Specification for Dissolution
Irbesartan Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
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
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Affected NDCs
68180-0410-06
68180-0410-09
Compare with the code on your package — it is the most precise check available.
Drug: Irbesartan Category: Blood Pressure Medication
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 68180-410-06
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0086-2022 · 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 Lupin Pharmaceuticals Inc.
All 2021 recalls
Class II · Moderate risk
Clobetasol Propionate Cream USP
Failed content uniformity specifications.
Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Class II · Moderate risk
prednisoLONE Acetate Ophthalmic Suspension
Presence of Foreign Substance
Class II · Moderate risk
Liraglutide Injection
Presence of particulate matter: a white thread-like structure in the cartridge
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