FDA recall D-0326-2017

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals · Class III · drug

Product

TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21

Reason for recall

Failed Stability Specifications

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-12-22
Report date
2017-01-11
Termination date
2017-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0326-2017