D-1271-2020 Class II Terminated
FDA drug recall D-1271-2020 was initiated by Mylan Institutional LLC on May 5, 2020 and is designated Class II. 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. The recall status is terminated (terminated January 26, 2022). Affected quantity: 3,010 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 27, 2020
- Initiation Date
- May 5, 2020
- Termination Date
- January 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,010 vials
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.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot #: Lot N1700771, EXP October 2020; Lot N1800127, EXP February 2021