Class II · Moderate risk Terminated
Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India…
Reason Failed Dissolution Specifications
Is Itraconazole recalled?
7 FDA recalls mention Itraconazole. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Itraconazole.
Class II · Moderate risk Terminated
Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4)…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class II · Moderate risk Terminated
ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas…
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Itraconazole 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
ITRACONAZOLE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147170003
Reason Labeling: Label Mixup; ITRACONAZOLE, Capsule, 100 mg may be potentially mislabeled as FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree…
Class II · Moderate risk Terminated
Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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