Nucala Injection Recalled for Temperature Abuse During Storage and Shipping
Cardinal Health is recalling 38 syringes of Nucala (mepolizumab) because the product was stored and shipped outside of labeled temperature requirements.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to temperature abuse, which is a potential risk to product stability but does not involve reported injuries or high-risk pathogens, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
Cardinal Health dba Specialty Pharmaceutical Services is recalling 38 syringes of Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose. The specific lot number is S25X, with an expiration date of 03/31/21. The product was distributed nationwide in the U.S.
The recall was initiated because the product was stored and shipped outside of its labeled storage requirements, a condition known as temperature abuse. This deviation from required storage conditions may affect the stability and efficacy of the medication.
Healthcare providers and patients who have received this specific lot of Nucala should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating a temporary or medically reversible adverse health consequence.
The recalled product
- Product
- NUCALA (MEPOLIZUMAB)
- Brand
- NUCALA
- Category
- Drug — Prescription Injection
- Affected units
- 38
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 #: S25X
- Exp. 03/31/21
Distribution
Distributed nationwide across the United States.
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