Drug product
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
D-1186-2018
Product summary
- Event
- Event 80782
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,799 bottles of 100
- Official record key
drug-enforcement:D-1186-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Code information: Batch code # 3093163, expiration date 04/2019
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Potency or specification failure
Out of specification