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
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling:Label Mixup; IRBESARTAN, Tablet, 150 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: W003597, EXP: 6/24/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD76686_7, EXP: 5/31/2014.
IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65862063830
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Out of Specification for Dissolution
Reason Failed Dissolution Specifications
Reason Failed dissolution specifications.
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
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