Why it was recalled
Lack of Assurance of Sterility
Product description
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Lot numbers, UPCs & expiration codes
Lot#: 11142022@12, Exp 12/29/2022
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0113-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 30, 2022
- FDA report date
- Jan 18, 2023
- Quantity
- 2 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Northern VA Compounders PLLC
Original FDA data
Every field from FDA enforcement report D-0113-2023, exactly as published.
Show all FDA fields
- City
- Sterling
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 91443
- Address
- 23475 Rock Haven Way
- Address (line 2)
- Suite 105
- Code information
- Lot#: 11142022@12, Exp 12/29/2022
- Postal code
- 20166-4444
- Report date
- Jan 18, 2023
- Product type
- Drugs
- Recall number
- D-0113-2023
- Classification
- Class II
- Recalling firm
- Northern VA Compounders PLLC
- Product quantity
- 2 vials
- Termination date
- Jun 21, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 30, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jan 12, 2023