Creon Capsule, Delayed Release Pellets
FDA Recall NDC 0032-0047
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Creon (NDC 0032-0047). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Abbvie Inc.. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
1669 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A.
Batch or Lot Expiration Information
Lot# 1139494
Affected Packages Involved in this Recall
0032-1203-70Product
0032-1203-64Product
0032-1206-07Product
0032-1206-01Product
0032-1206-56Product
0032-1212-07Product
0032-1212-01Product
0032-1212-46Product
0032-1212-13Product
0032-1224-07Product
0032-1224-01Product
0032-1224-46Product
0032-3016-28Product
0032-3016-13Product
0032-3016-50Product
0032-3016-12Product
0032-0045-70Product
0032-0045-30Product
0032-0046-30Product
0032-0046-70Product
0032-0047-30Product
0032-0047-70Product
0032-2636-70Product
0032-2636-01Product
0032-2636-30Product
0032-2637-70Product
0032-2637-01Product
0032-2637-30Product
September 2014 Class II Recall: Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Recall Number
Class II Terminated
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Sep 15, 2014
Oct 08, 2014
18,021 Bottles
Recall Profile & Regulatory Data
Event ID
69285
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AbbVie Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US: Nationwide
Termination Date
Jun 22, 2016
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.
Batch or Lot Expiration Information
Lot# : 1020156; Expiry: 3/31/2016
Affected Packages Involved in this Recall
0032-1203-70Product
0032-1203-64Product
0032-1206-07Product
0032-1206-01Product
0032-1206-56Product
0032-1212-07Product
0032-1212-01Product
0032-1212-46Product
0032-1212-13Product
0032-1224-07Product
0032-1224-01Product
0032-1224-46Product
0032-3016-28Product
0032-3016-13Product
0032-3016-50Product
0032-3016-12Product
0032-0045-70Product
0032-0045-30Product
0032-0046-30Product
0032-0046-70Product
0032-0047-30Product
0032-0047-70Product
0032-2636-70Product
0032-2636-01Product
0032-2636-30Product
0032-2637-70Product
0032-2637-01Product
0032-2637-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
