Home / Recalls / Mylan Pharmaceuticals Inc. / D-0506-2019

D-0506-2019 Class III Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
February 27, 2019
Initiation Date
February 13, 2019
Termination Date
September 12, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,159 bottles

Product Description

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

Distribution Pattern

Throughout the United States

Code Information

Lot #: 3090167, Exp. October 2019

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