FDA-Drug2018-08-29Class III
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
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Hazard
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Sold states
Nationwide USA
Affected count
408 cartons
Manufactured in
1718 Northrock Ct, Rockford, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1112-2018Don't want to check this manually?
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