FDA recall D-1435-2014

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

Product

Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.

Reason for recall

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

Distribution

Nationwide, Puerto Rico, and Guam.

Key facts

Status: Terminated
Initiation date: 2014-07-03
Report date: 2014-07-23
Termination date: 2016-07-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1435-2014