FDA recall D-0506-2019

Mylan Pharmaceuticals Inc. · Class III · drug

Product

Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505

Reason for recall

Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing

Distribution

Throughout the United States

Key facts

Status: Terminated
Initiation date: 2019-02-13
Report date: 2019-02-27
Termination date: 2019-09-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0506-2019