FDA recall D-0810-2016

Product

Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.

Reason for recall

Failed Dissolution Specifications

Distribution

U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.

Key facts

Status

Terminated

Initiation date

2016-03-31

Report date

2016-04-13

Termination date

2017-04-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stamford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0810-2016