Drug product
Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
D-1112-2018
Product summary
- Event
- Event 80802
- Status
- Terminated
- Classification
- Class III
- Quantity
- 408 cartons
- Official record key
drug-enforcement:D-1112-2018
Official wording
Reason: Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Code information: Batch 3096049
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
out of specification