US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 4, 2017 (9 years ago)

Viokace

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

Why it was recalled

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

What was recalled

Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10

Recalling firm
Allergan
NDC code
58914-117-10
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0154-2018

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

See all
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

Creon

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

AbbVie Inc NDC 0032-1224-07 D-1611-2014
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