Mylan Recalls Aloprim Injection Vials Due to Discoloration
Mylan Institutional LLC is recalling 3,010 vials of Aloprim (allopurinol sodium) for Injection due to out-of-specification appearance and color results.
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 and involves a cosmetic defect (discoloration) with no reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Mylan Institutional LLC is voluntarily recalling 3,010 vials of Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial. The affected product is distributed nationwide in the USA. The specific lots involved are N1700771 (expiration October 2020) and N1800127 (expiration February 2021).
The recall was initiated because routine stability testing at the end of the shelf-life revealed out-of-specification results for the appearance and color of the solution. This indicates the product did not meet the required visual standards for its stated shelf life.
Healthcare providers and patients should discontinue use of the affected lots and contact Mylan Institutional LLC for further instructions. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- ALOPRIM (ALLOPURINOL)
- Brand
- ALOPRIM
- Manufacturer
- Mylan Institutional LLC
- Category
- Drug — Prescription Injection
- Affected units
- 3,010
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 (4)
- Lot #: Lot N1700771
- EXP October 2020
- Lot N1800127
- EXP February 2021
Distribution
Distributed nationwide across the United States.
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