FDA recall D-1278-2015

Product

Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30

Reason for recall

Failed dissolution specifications

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-07-13

Report date

2015-07-29

Termination date

2017-05-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stamford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1278-2015