FDA-Drug2016-11-30Class III
Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
Mylan Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: OOS results for known compound.
Sold states
Nationwide
Affected count
51,983 extended release capsules
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0151-2017Don't want to check this manually?
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