FDA recall D-0478-2017

Product

Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17

Reason for recall

Failed tablet/capsule specification: missing break line on the 5mg tablet.

Distribution

U.S. Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-12-20

Report date

2017-02-22

Termination date

2017-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0478-2017