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
Reported: May 27, 2020 Initiated: May 5, 2020 #D-1271-2020
Product Description
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.
Details
- Recalling Firm
- Mylan Institutional LLC
- Units Affected
- 3,010 vials
- Distribution
- Distributed Nationwide in the USA
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mylan Institutional LLC. Units affected: 3,010 vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 27, 2020. Severity: Moderate. Recall number: D-1271-2020.
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