Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9354-07
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Drug: Fluvastatin
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.
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.
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.
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.
Failed Dissolution Specifications
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
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