Recalls / Class II
Class IID-0402-2021
Product
Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A.
- 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
- 1139494
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- AbbVie Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 1669 bottles
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0402-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.