FDAFDA · Food and drugs·Recall number D-1557-2014
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
Published September 3, 2014 · Recall initiated: June 19, 2014
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 for a related compound obtained during routine stability testing.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Nationwide
- Lot
- Lot 3040063 Exp. 07/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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