CLASS II Drug recall · Reported 18 Jan 2023 · FDA Enforcement Report
TriMix Injection (PGE1/Papaverine HCl/Phentolamine recalled
Northern VA Compounders P is recalling TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL, distributed nationwide in the US. The recall was initiated on 30 Dec 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0118-2023
- FDA event ID
- 91443
- Recalling firm
- Northern VA Compounders P, Sterling, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Dec 2022
- FDA classified
- 12 Jan 2023
- Reported
- 18 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Dec 2022 | Recall initiated by company | |
| 12 Jan 2023 | Classified by FDA | +13 days |
| 18 Jan 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot#: 11262022@8, Exp 1/10/2023; 11302022@12, Exp 1/14/2023
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
24 other products · FDA event 91443This product is part of a recall event; the main page for the event is QuadMix Plus (PGE1/Papaverine HCl/Phentolamine recalled.
More recalls from Northern VA Compounders P
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prostaglandin (E1) Injection Solution, 10 mcg/ml recalled | Northern VA Compounders P | Sterility | Nationwide |
| Drug | CLASS II | QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine recalled | Northern VA Compounders P | Sterility | Nationwide |
| Drug | CLASS II | QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine recalled | Northern VA Compounders P | Sterility | Nationwide |
| Drug | CLASS II | TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) recalled | Northern VA Compounders P | Sterility | Nationwide |
| Drug | CLASS II | BiMix Injection (Papaverine HCl/Phentolamine Mesylate) recalled | Northern VA Compounders P | Sterility | Nationwide |
Other Trimix recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | TriMix Injection (PGE1/Papaverine HCl/Phentolamine recalled | Northern VA Compounders P | Sterility | Nationwide |
| Drug | CLASS II | TriMix Injection (PGE1/Papaverine HCl/Phentolamine recalled | Northern VA Compounders P | Sterility | Nationwide |
| Drug | CLASS II | TriMix Injection (PGE1/Papaverine HCl/Phentolamine) recalled | Northern VA Compounders P | Sterility | Nationwide |
| Drug | CLASS II | TriMix Injection (PGE1/Papaverine HCl/Phentolamine recalled | Northern VA Compounders P | Sterility | Nationwide |
| Drug | CLASS II | TriMix Injection (PGE1/Papaverine HCl/Phentolamine recalled | Northern VA Compounders P | Sterility | Nationwide |