FDA recall D-1271-2020

Product

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

Reason for recall

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.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-05-05

Report date

2020-05-27

Termination date

2022-01-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1271-2020