Class III · Low risk Ongoing
PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA…
Reason Failed Stability Specifications
Is Pancrelipase recalled?
8 FDA recalls mention Pancrelipase. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pancrelipase.
Class II · Moderate risk Terminated
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.
Class II · Moderate risk Terminated
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.
Class II · Moderate risk Terminated
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.
Class II · Moderate risk Terminated
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…
Class II · Moderate risk Terminated
PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032121207.
Reason Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as the following drug: ASPIRIN/ER…
Class II · Moderate risk Terminated
PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032121201.
Reason Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as one of the following drugs: ASCORBIC…
Class II · Moderate risk Terminated
PANCRELIPASE DR Capsule, Rx only, Distributed by: AidaPak Service, LLC, NDC 42865010302
Reason Labeling: Label Mixup; PANCRELIPASE DR Capsule may be potentially mislabeled as MELATONIN, Tablet, 1 mg, NDC 35046000391, Pedigree: W003317, EXP…
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