AbbVie Recalls CREON Capsules Due to Foreign Tablets and Co-mingled Product
AbbVie is recalling 18,021 bottles of CREON (pancrelipase) capsules because some bottles contain foreign tablets or co-mingled LipaCreon 13000.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe) unless specific hospitalization reports are present, which are not mentioned in the source text.
Plain-English summary
AbbVie Inc. is recalling 18,021 bottles of CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles. The recall is due to the presence of foreign tablets or capsules and the presence of co-mingled LipaCreon 13000 in the product.
The affected product is identified by Lot # 1020156 with an expiry date of 3/31/2016. The product was distributed nationwide in the United States. CREON is a prescription-only medication marketed by AbbVie Inc. in North Chicago, IL, and is a product of Germany.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CREON (PANCRELIPASE)
- Brand
- CREON
- Manufacturer
- AbbVie Inc
- Category
- Drug — Prescription Drug
- Affected units
- 18,021
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1020156
- Expiry: 3/31/2016
UPCs (8)
- 0300322637701
- 0300320045706
- 0300320047700
- 0300320046703
- 0300323016130
- 0300322636704
- 0300321212077
- 0300321224018
Distribution
Distributed nationwide across the United States.
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