Mylan Institutional LLC recalls Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC…

Recall date

May 5, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1271-2020

FDA classification

Class II

Brand / firm

Mylan Institutional LLC

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50