FDAClass IIOctober 24, 2018

Clonazepam Orally Disintegrating Tablets USP recall

Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96

Why was Clonazepam Orally Disintegrating Tablets USP recalled?

Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 34033752A, EXP 1/2020

Product
Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
Recalling firm
Teva Pharmaceuticals USA
Quantity
1,373 60-count cartons
Distribution
Product was distributed throughout the United States to various distributors who may have further distributed the product.
Recall date
October 24, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls