Drug product
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
D-0506-2019
Product summary
- Event
- Event 82086
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,159 bottles
- Official record key
drug-enforcement:D-0506-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Code information: Lot #: 3090167, Exp. October 2019
Distribution pattern: Throughout the United States
Derived failure modes
-
Potency or specification failure
out of specification