Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only

Recalled July 23, 2014 · FDA recall D-1435-2014 · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Hazard

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. · FDA Class III

Units

1,184 cartons

Sold at

Nationwide, Puerto Rico, and Guam.

Description

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Product

Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.

Manufacturer(s)

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

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →