Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx On…

Recall date

August 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1112-2018

FDA classification

Class III

Brand / firm

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Sold / distributed

Nationwide USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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