Drug product
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
D-1557-2014
Product summary
- Event
- Event 68645
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,658 Bottles
- Official record key
drug-enforcement:D-1557-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Code information: Lot 3040063 Exp. 07/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out-of-specification