Recalls / Class II
Class IID-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.
- Brand name
- Creon
- Generic name
- Pancrelipase
- Active ingredients
- Pancrelipase Amylase, Pancrelipase Lipase, Pancrelipase Protease
- Route
- Oral
- NDCs
- 0032-0045, 0032-1203, 0032-1206, 0032-1212, 0032-1224, 0032-3016, 0032-0046, 0032-0047, 0032-2636, 0032-2637
- FDA application
- BLA020725
- Affected lot / code info
- Lot #: 1020156; Expiry: 3/31/2016
Why it was recalled
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Recalling firm
- Firm
- AbbVie Inc
- Manufacturer
- AbbVie Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 N Waukegan Rd, N/A, North Chicago, Illinois 60064
Distribution
- Quantity
- 18,021 Bottles
- Distribution pattern
- US: Nationwide
Timeline
- Recall initiated
- 2014-09-15
- FDA classified
- 2014-09-26
- Posted by FDA
- 2014-10-08
- Terminated
- 2016-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1611-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.