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U.S. Department of Health and Human Services

Enforcement Report - Week of October 7, 2014

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Product Detail

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.
Recall Number D-1611-2014
Classification Class II
Code Info Lot #: 1020156; Expiry: 3/31/2016
Product Distributed Qty 18,021 Bottles
Reason For Recall Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.

Event Detail

Event Id 69285
Product Type Drugs
Status Ongoing
Recalling Firm AbbVie Inc
City North Chicago
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-09-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US: Nationwide