PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, Rx only, Distributed by: AidaPak…

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

Recalling firm

Aidapak Services, LLC

Origin

WA, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-784-2014

Other Pancrelipase recalls

See all

Class III · Low risk Ongoing Jun 23, 2023

PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA…

Reason Failed Stability Specifications

Vivus, Inc. NDC 62541-401-10 D-0896-2023

Class II · Moderate risk Terminated Mar 15, 2021

Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules…

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 Dec 4, 2017

Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612…

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 Sep 15, 2014

CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc…

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 Jul 2, 2013

PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032122401.

Reason Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potentially mislabeled as one of the following drugs…

Aidapak Services, LLC D-785-2014