FDA-Drug2018-09-19Class III

Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01

Mylan Pharmaceuticals Inc.
Hazard

Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

Sold states
Distributed Nationwide in the US
Affected count
11,799 bottles of 100
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1186-2018

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