FDA recall D-0082-2019

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

Reason for recall

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

Distribution

Product was distributed throughout the United States to various distributors who may have further distributed the product.

Key facts

Status

Terminated

Initiation date

2018-09-20

Report date

2018-10-24

Termination date

2019-11-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0082-2019