Class II · Moderate risk Terminated
Irbesartan Bulk Active Pharmaceutical Ingredient.
Reason CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
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 III · Low risk Terminated
Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002…
Class III · Low risk Terminated
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA…
Reason Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Class II · Moderate risk Terminated
Irbesartan active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093746556.
Reason Labeling: Label Mixup: IRBESARTAN, Tablet, 150 mg may have potentially been mislabeled as the following drug: BENAZEPRIL HCL, Tablet, 40 mg, NDC…
Class II · Moderate risk Terminated
IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65862063830
Reason Labeling:Label Mixup; IRBESARTAN, Tablet, 150 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC…
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