ITRACONAZOLE 100 mg/1

Well Care Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Aidapak Services, LLC

Labeling: Label Mixup; ITRACONAZOLE, Capsule, 100 mg may be potentially mislabeled as FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD54549_4, EXP: 5/20/2014.

Well Care Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Jubilant Cadista Pharmaceuticals, Inc.

Failed Dissolution Specifications

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Clinical Specialties Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

American Pharmaceutical Ingredients LLC

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.