Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, W…
- Recall date
- August 7, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1186-2018
- FDA classification
- Class III
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- Distributed Nationwide in the US
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
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