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FDAFDA · Food and drugs·Recall number D-1112-2018

Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08

Published August 29, 2018 · Recall initiated: August 14, 2018

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Distributor
Nationwide USA
Lot
Batch 3096049
Risk classification
Class III
Area (FDA)
drug
Country
United States

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