FDA recall D-1611-2014

Product

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.

Distribution

US: Nationwide

Key facts

Status

Terminated

Initiation date

2014-09-15

Report date

2014-10-08

Termination date

2016-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1611-2014