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

FDA recall notice · announced May 27, 2020 · Mylan Institutional

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

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.

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot #: Lot N1700771, EXP October 2020; Lot N1800127, EXP February 2021
Quantity: 3,010 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.