Drug product
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
D-0108-2021
Product summary
- Event
- Event 86659
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7176 bottles
- Official record key
drug-enforcement:D-0108-2021
Official wording
Reason: Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Code information: Lot #: 18029979, Exp 1/2021
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification