FDA-Drug2019-02-27Class III
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
Mylan Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Sold states
Throughout the United States
Affected count
8,159 bottles
Manufactured in
781 Chestnut Ridge Rd, Morgantown, WV, United States
Products
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0506-2019Don't want to check this manually?
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