FDA recall D-0716-2018

Mckesson Packaging Services · Class III · drug

Product

Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10

Reason for recall

Failed Dissolution Specifications. High dissolution results were obtained during stability testing.

Distribution

Nationwide with the US

Key facts

Status: Terminated
Initiation date: 2018-04-23
Report date: 2018-05-02
Termination date: 2020-10-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Concord, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0716-2018