Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
What was recalled
CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96
Recalling firm
Teva Pharmaceuticals USA, Inc.
NDC code
0555-0096-96
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-237-2013
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 Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the…