FDA recall D-0151-2017

Product

Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA

Reason for recall

Failed Impurities/Degradation Specifications: OOS results for known compound.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-11-03

Report date

2016-11-30

Termination date

2017-08-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0151-2017