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.
Reported: January 18, 2023 Initiated: December 30, 2022 #D-0125-2023
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
Details
- Recalling Firm
- Northern VA Compounders PLLC
- Units Affected
- 1200 vials
- Distribution
- Nationwide in the USA
- Location
- Sterling, VA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Northern VA Compounders PLLC. Units affected: 1200 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 18, 2023. Severity: Moderate. Recall number: D-0125-2023.
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