Bristol-Myers Squibb Recalls Eliquis 5mg Tablets Due to Labeling Error
Bristol-Myers Squibb is recalling 48,180 bottles of Eliquis 5mg tablets because one bottle was found to contain 2.5mg tablets instead.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 I, which per the rubric mandates a minimum score of 4 (Severe).
Plain-English summary
Bristol-Myers Squibb Company is recalling 48,180 bottles of Eliquis 5mg tablets, 60-count bottles, NDC 0003-0894-21. The recall is due to a labeling error where one bottle was found to contain lower-strength Eliquis 2.5mg tablets instead of the labeled 5mg tablets.
The affected product is identified by Lot HN0063 with an expiration date of 09/2019. The product was distributed nationwide in the US.
Consumers should check their medication for this specific lot number and expiration date. If they have the affected product, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA and Pfizer Inc. New York, NY 10017 USA, NDC 0003-0894-21
- Manufacturer
- Bristol-myers Squibb Company
- Category
- Drug — Anticoagulant
- Affected units
- 48,180
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: HN0063
- EXP. 09/2019
Distribution
Distributed nationwide across the United States.
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