FDA recall D-1187-2018

Mylan Pharmaceuticals Inc. · Class III · drug

Product

Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

Distribution

Distributed Nationwide in the US

Key facts

Status
Terminated
Initiation date
2018-08-07
Report date
2018-09-19
Termination date
2019-08-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1187-2018