Class I · High risk
Papaverine HCl Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Tri-Mix Papaverine 30/Phentolamine 2/Pge-1 40 Inj Injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility
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
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Drug: Papaverine
- Recalling firm
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0213-2022 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy
All 2021 recalls
Class II · Moderate risk
Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 40 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 10 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 30/Phentolamine 6/Pge-1 60 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 7.5/Ml Inj Injectable
Lack of assurance of sterility
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