FDA Drug recall D-0104-2023
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-D…
- FDA Drug
- Class II
- terminated
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-D… by Northern Va Compounders Pllc, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0104-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-12-30 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Northern Va Compounders Pllc |
| Distribution | US |
Product
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot#: 12012022@11, Exp 1/15/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0104-2023%22
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