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.
FDA recall notice · announced October 8, 2014 · Abbvie
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Notes
Distribution: US: Nationwide
Lot/code information: Lot #: 1020156; Expiry: 3/31/2016
Quantity: 18,021 Bottles
Status: Terminated
Products in this recall event:
- 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. (D-1611-2014)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.