Drug recall D-0506-2019

Class III Terminated reported Feb 27, 2019

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

Lots and codes

Lot #: 3090167, Exp. October 2019

Recall details

Recalling firm
Mylan Pharmaceuticals Inc., Morgantown, WV
Quantity
8,159 bottles
Distribution
Throughout the United States
Type
Voluntary: Firm initiated
Recall initiated
February 13, 2019
Terminated
September 12, 2019