ScieGen Pharmaceuticals Inc. is recalling some lots of Irbesartan tablets because they may be contaminated with an impurity.
The impurity, N-nitrosodiethylamine, is classified as a probable human carcinogen by the International Agency for Research on Cancer.
The Irbesartan tablets recalled include 75 mg., 150 mg., and 300 mg. dosages and were manufactured by Aurobindo Pharma Limited.
The company said it hasn’t received any reports of adverse events about the tablets in the recall.
Irbesartan is used to treat hypertension. It can be used alone or in combination with other blood pressure medications.
The Irbesartan tablets were manufactured by ScieGen Pharmaceuticals Inc. and are labeled as Westminster Pharmaceuticals and Golden State Medical Supply Inc. The recalls and returns will be managed by the two distributors.
The U.S. Food and Drug Administration has published a list of the lots affected by the recall.
If you’re taking Irbesartan, look for markings to determine if you’re tablets are affected by this recall. The tablets can be identified as being white, oval shaped tablets with SG 160, SG 161, or SG 162 stamped into the surface.
Consumers should contact their pharmacist or physician who can tell them about an alternative treatment before returning their medication. They should contact their physician or healthcare provider if they’ve experienced any problems that could be related to taking or using Irbesartan.
Adverse reactions or quality problems experienced with the use of Irbesartan can be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and submit the report online: fda.gov/medwatch/report.htm.
- Regular mail or fax: Download form fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 800-FDA-0178.
For details on other recalls, see www.recalls.gov.
