Drug 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

D-1271-2020

May 05, 2020

Class II

Product summary

Firm: Mylan Institutional LLC
Event: Event 85624
Status: Terminated
Classification: Class II
Quantity: 3,010 vials
Official record key: drug-enforcement:D-1271-2020

Official wording

Reason: 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.

Code information: Lot #: Lot N1700771, EXP October 2020; Lot N1800127, EXP February 2021

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Out-of-specification