PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: October 8, 2014 Initiated: September 15, 2014 #D-1611-2014

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.

Reason for Recall

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

Details

Recalling Firm
AbbVie Inc
Units Affected
18,021 Bottles
Distribution
US: Nationwide
Location
North Chicago, IL

Frequently Asked Questions

What product 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.. Recalled by AbbVie Inc. Units affected: 18,021 Bottles.
Why was this product recalled?
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 8, 2014. Severity: Moderate. Recall number: D-1611-2014.