D-0748-2020 Class II Terminated
FDA drug recall D-0748-2020 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: 5 vials.
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
- 5 vials
Product Description
IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
Nationwide within the United States
Code Information
Lots: 07162019@20 Exp. 01/12/2020; 12102019@17 Exp. 06/07/2020; 07162019@20 Exp. 01/12/2020