Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-52…
- Recall date
- November 3, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0151-2017
- FDA classification
- Class III
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: OOS results for known 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 (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
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