Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
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 Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradations Specifications
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Reason Lack of Assurance of Sterility
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