D-0125-2023 Class II Terminated
FDA drug recall D-0125-2023 was initiated by Northern VA Compounders PLLC on December 30, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated June 21, 2023). Affected quantity: 1200 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- January 18, 2023
- Initiation Date
- December 30, 2022
- Termination Date
- June 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1200 vials
Product Description
BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot#: 10252022@3, Exp 1/31/2023