Class I · High risk
Papaverine HCl Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Papaverine / Phentolamine Injection 150mg / 5mg / Vial Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drug: Papaverine
- Recalling firm
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Origin
- MS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0046-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Papaverine recalls
See all
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix STD 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Plus 002
Lack of Assurance of Sterility
Other recalls by Pharmacy Plus, Inc. dba Vital Care Compounder
All 2022 recalls
Class II · Moderate risk
C-Semaglutide 5mg/mL injection
Lack of assurance of sterility.
Class II · Moderate risk
Voriconazole Opth Solution 2% Sterile Soln
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Vancomycin Intravitreal 1mg/0.1ml Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Talc
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
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