Drug product
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.
D-1435-2014
Product summary
- Event
- Event 68787
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,184 cartons
- Official record key
drug-enforcement:D-1435-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Code information: Lot #: 3045659, 3048256, Exp 07/14
Distribution pattern: Nationwide, Puerto Rico, and Guam.
Derived failure modes
-
Potency or specification failure
out-of-specification