Class II · Moderate risk
Irbesartan Tablets USP
Out of Specification for Dissolution
GSMS 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 presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
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
GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
Affected NDCs
60429-0642-30
60429-0642-90
Compare with the code on your package — it is the most precise check available.
Drug: Irbesartan Category: Blood Pressure Medication
- Recalling firm
- Sciegen Pharmaceuticals Inc
- NDC code
- 60429-642-30
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0272-2019 · 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 Sciegen Pharmaceuticals Inc
All 2018 recalls
Class III · Low risk
Gabapentin Tablets
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Class II · Moderate risk
GSMS Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
GSMS Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Westminister Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
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