FDA recall D-1112-2018

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Class III · drug

Product

Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08

Reason for recall

Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer

Distribution

Nationwide USA

Key facts

Status: Terminated
Initiation date: 2018-08-14
Report date: 2018-08-29
Termination date: 2020-06-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1112-2018