Recalls / Class II
Class IID-1271-2020
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
- Brand name
- Aloprim
- Generic name
- Allopurinol
- Active ingredient
- Allopurinol Sodium
- Route
- Intravenous
- NDC
- 67457-187
- FDA application
- NDA020298
- Affected lot / code info
- Lot #: Lot N1700771, EXP October 2020; Lot N1800127, EXP February 2021
Why it was 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.
Recalling firm
- Firm
- Mylan Institutional LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4901 Hiawatha Dr, N/A, Rockford, Illinois 61103-1287
Distribution
- Quantity
- 3,010 vials
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-05-05
- FDA classified
- 2020-05-20
- Posted by FDA
- 2020-05-27
- Terminated
- 2022-01-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1271-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.