Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56
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 Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Reason Labeling: Label Mixup: FLUVASTATIN, Capsule, 20 mg may have potentially been mislabeled as the following drug: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg, NDC 00603254421, Pedigree: W002654, EXP: 6/4/2014.
Reason Labeling: Label Mixup: FLUVASTATIN SODIUM, Capsule, 20 mg may have potentially been mislabeled as the following drug: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD73597_1, EXP: 5/31/2014.
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