Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories…
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD73525_40, EXP: 5/30/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003005, EXP: 6/11/2014; carBAMazepine ER, Tablet, 100 mg, NDC 00078051005, Pedigree: W003330, EXP: 6/18/2014.
MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141503
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 Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradations Specifications
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Reason Lack of Assurance of Sterility
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