FDA-Drug2014-09-03Class III
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
Mylan Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Sold states
Nationwide
Affected count
2,658 Bottles
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1557-2014Don't want to check this manually?
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