May 2020 FDA Recall Aloprim by Mylan Institutional Llc
D-1271-2020 - Discoloration

This Class II drug recall was voluntarily initiated by Mylan Institutional Llc on May 5, 2020 for the product Aloprim. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1271-2020

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.
Initiated
05-05-2020
Reported
05-27-2020
Quantity
3,010 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85624
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mylan Institutional LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

67457-187-50 Aloprim