FDAFDA · Food and drugs·Recall number D-0506-2019
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
Published February 27, 2019 · Recall initiated: February 13, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Throughout the United States
- Lot
- Lot #: 3090167, Exp. October 2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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