Reported Aug 29, 2018 · Terminated

Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx…

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

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · 1718 Northrock Ct · Rockford, IL · 61103-1201

Is this the product you have?

  • Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only
  • Manufactured byMylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
Lot codes and dates
  • Batch 3096049
Amount recalled
408 cartons

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 26, 2020 · Data as of Sep 19, 7:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.