RecallRadar

FDA Drug recall D-1271-2020

Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103…

On 2020-05-27 the FDA classified a Class II recall of Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103… by Mylan Institutional, citing 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.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1271-2020
ClassificationClass II
Statusterminated
Initiated2020-05-05
Published2020-05-27
Last updated2026-09-13 11:52 UTC
CompanyMylan Institutional
DistributionUS

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

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.

Identifiers

ndc67457-187-50
code_infoLot #: Lot N1700771, EXP October 2020; Lot N1800127, EXP February 2021

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1271-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.