Reported Jul 23, 2014 · Terminated
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards 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, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only
- Manufactured byMylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08
- Lot codes and dates
Lot #: 30456593048256Exp 07/14
- Amount recalled
- 1,184 cartons
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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