US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 15, 2014 (12 years ago)

Creon

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.

What was recalled

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.

Recalling firm
AbbVie Inc
NDC code
0032-1224-07
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1611-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Pancrelipase recalls

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Class III · Low risk Ongoing

Pancreaze

Reason Failed Stability Specifications

Vivus, Inc. NDC 62541-401-10 D-0896-2023
Class II · Moderate risk Terminated

Creon

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 0032-3016-13 D-0402-2021
Class II · Moderate risk Terminated

Viokace

Reason Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.

Allergan NDC 58914-117-10 D-0154-2018
Class II · Moderate risk Terminated

Pancrelipase Dr

Reason Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potentially mislabeled as one of the following drugs: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD70585_7, EXP: 5/29/2014; THYROID, Tablet, 60 mg, NDC 00456045901, Pedigree: W002848, EXP: 6/7/2014; CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: W003744, EXP: 6/26/2014; amLOD

Aidapak Services, LLC D-785-2014
Class II · Moderate risk Terminated

Pancrelipase Dr

Reason Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as the following drug: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: AD70639_4, EXP: 7/28/2013.

Aidapak Services, LLC D-784-2014