D-1611-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 8, 2014
- Initiation Date
- September 15, 2014
- Termination Date
- June 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,021 Bottles
Product Description
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.
Reason for Recall
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Distribution Pattern
US: Nationwide
Code Information
Lot #: 1020156; Expiry: 3/31/2016