Class II · Moderate risk Ongoing
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC…
Reason Out of Specification for Dissolution
Is Irbesartan recalled?
31 FDA recalls mention Irbesartan. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Irbesartan.
Class II · Moderate risk Terminated
Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India…
Reason Failed dissolution specifications.
Class II · Moderate risk Terminated
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09)…
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk Terminated
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09)…
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk Terminated
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk Terminated
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk Terminated
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk Completed
Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Class II · Moderate risk Completed
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Class II · Moderate risk Completed
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Class II · Moderate risk Completed
Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Class II · Moderate risk Completed
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Class II · Moderate risk Terminated
IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only…
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Class II · Moderate risk Terminated
IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only…
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Class II · Moderate risk Terminated
IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788…
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Class II · Moderate risk Terminated
Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788…
Reason CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk Terminated
Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788…
Reason CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk Terminated
Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured…
Reason CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk Terminated
GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only…
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only…
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788…
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC…
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx…
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx…
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
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