D-0681-2020 Class II Terminated
FDA drug recall D-0681-2020 was initiated by Assurance Infusion on December 20, 2019 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated October 27, 2021). Affected quantity: 1 syringe.
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2020
- Initiation Date
- December 20, 2019
- Termination Date
- October 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 syringe
Product Description
BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
Nationwide within the United States
Code Information
Lot: 12112019@8 Exp. 12/20/2019