Why it was recalled
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
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.
Lot numbers, UPCs & expiration codes
Lot #: 1020156; Expiry: 3/31/2016
Where it was sold
US: Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1611-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 15, 2014
- FDA report date
- Oct 8, 2014
- Quantity
- 18,021 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AbbVie Inc
Original FDA data
Every field from FDA enforcement report D-1611-2014, exactly as published.
Show all FDA fields
- City
- North Chicago
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69285
- Address
- 1 N Waukegan Rd
- Code information
- Lot #: 1020156; Expiry: 3/31/2016
- Postal code
- 60064
- Report date
- Oct 8, 2014
- Product type
- Drugs
- Recall number
- D-1611-2014
- Classification
- Class II
- Recalling firm
- AbbVie Inc
- Product quantity
- 18,021 Bottles
- Termination date
- Jun 22, 2016
- Reason for recall
- Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- US: Nationwide
- Recall initiation date
- Sep 15, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 26, 2014