FDA-Drug2014-07-23Class III
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.
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.
Sold states
Nationwide, Puerto Rico, and Guam.
Affected count
1,184 cartons
Manufactured in
1718 Northrock Ct, N/A, Rockford, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1435-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief