Recalls / Class II
Class IID-0108-2023
Product
QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/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.
- Affected lot / code info
- Lot#: 12062022@1, Exp 1/20/2023
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Northern VA Compounders PLLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 23475 Rock Haven Way, Suite 105, Sterling, Virginia 20166-4444
Distribution
- Quantity
- 6 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-12-30
- FDA classified
- 2023-01-12
- Posted by FDA
- 2023-01-18
- Terminated
- 2023-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0108-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.