Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceuticals North America, Bridgewater, NJ 08807 USA, NDC 0187-0007-14.
Compare with the code on your package — it is the most precise check available.
Drug: Ribavirin
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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.
Labeling:Label Mixup; RIBAVIRIN, Capsule, 200 mg may be potentially mislabeled as MODAFINIL, Tablet, 50 mg (1/2 of 100 MG Tablet), NDC 55253080130, Pedigree: AD21787_4, EXP: 5/1/2014; DESIPRAMINE HCL, Tablet, 50 mg, NDC 45963034302, Pedigree: AD30140_7, EXP: 5/7/2014.
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
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