FDA recall D-0715-2018

Mckesson Packaging Services · Class III · drug

Product

Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10

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-0715-2018