Drug product
CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07.
D-1611-2014
Product summary
- Firm
- AbbVie Inc
- Event
- Event 69285
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,021 Bottles
- Official record key
drug-enforcement:D-1611-2014
Official wording
Reason: Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Code information: Lot #: 1020156; Expiry: 3/31/2016
Distribution pattern: US: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets