GlaxoSmithKline Recalls Arranon Injection Due to Potential Impurities
GlaxoSmithKline is recalling specific lots of Arranon (nelarabine) Injection because drug-related impurities may exceed specification limits.
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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as the agency's own classification mandates a score of at least 4.
Plain-English summary
GlaxoSmithKline, LLC. is recalling 1,319 vials of Arranon (nelarabine) Injection 5mg/mL, 50mL Vials. The affected product is prescription-only and intended for intravenous infusion. The recall covers lots C536707, C538830, and C533169, all with an expiration date of 02/14. The product was distributed nationwide.
The recall was initiated because there is a potential for drug-related impurities to exceed specification limits. The agency has classified this recall as Class II.
Healthcare providers and patients should stop using the affected lots of Arranon and contact their healthcare provider or GlaxoSmithKline for further instructions.
The recalled product
- Product
- Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06
- Manufacturer
- GlaxoSmithKline, LLC.
- Category
- Drug — Injection
- Hazard
- Affected units
- 1,319
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 (3)
- Lot # C536707 Exp 02/14
- C538830 Exp.02/14
- C533169 Exp. 02/14
Distribution
Distributed nationwide across the United States.
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