FDA-Drug2018-09-19Class III

Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05

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
656 500-count bottles
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, 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-1187-2018

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