Drug product
AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217
D-0144-2017
Product summary
- Event
- Event 75470
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5283 cartons (100 capsules per carton = 528,300 capsules)
- Official record key
drug-enforcement:D-0144-2017
Official wording
Reason: Presence of Foreign Tablets/Capsules
Code information: Lot #155404 ; Exp 01/18 Lot #161139,163060,164054, 164809; Exp 03/18
Distribution pattern: US
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets