Class I · High risk
Papaverine HCl Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
TriMix MEDIUM
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility for injectables and solutions intended 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
TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
Drug: Papaverine
- Recalling firm
- Customceutical Compounding
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1262-2019 · 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 Customceutical Compounding
All 2019 recalls
Class II · Moderate risk
Trimix HIGH
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Test PROCYP
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Test D (Testosterone Cypionate 200mg/Ml Vitamin D3 5,000iu/Ml)
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Test D (Testosterone Cypionate 200mg/Ml Vitamin D3 5,000iu/Ml)
Lack of assurance of sterility for injectables and solutions intended to be sterile.
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