Gsms irbesartan recalls
The FDA has published 3 recalls involving Gsms irbesartan since 2018. The latest was reported on 28 Nov 2018. Most were for nitrosamine impurity. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls3since 2018
Last 12 months0reported
Class I00% of total
Ongoing0latest 28 Nov 2018
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 100%Class III 0 0%
Why gsms irbesartan is recalled
Companies
By year
All gsms irbesartan recalls, newest first
3 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | GSMS Irbesartan Tablets, USP, 300 mg,(a) bottle recalled | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | GSMS Irbesartan Tablets, USP, 75 mg recalled by Sciegen Pharmaceuticals | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | GSMS Irbesartan Tablets, USP, 150 mg, (a) bottle recalled | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Should you stop taking Gsms irbesartan?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.