FDA recall D-1557-2014

Product

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

Reason for recall

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-06-19

Report date

2014-09-03

Termination date

2015-07-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1557-2014