FDAFDA · Food and drugs·Recall number D-1435-2014
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
Published July 23, 2014 · Recall initiated: July 3, 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 · Letter
Recall details
- Manufacturer
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Distributor
- Nationwide, Puerto Rico, and Guam.
- Lot
- Lot #: 3045659, 3048256, Exp 07/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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