CLASS II Drug recall · Reported 8 May 2019 · FDA Enforcement Report
Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate recalled
Customceutical Compounding is recalling Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), distributed nationwide in the US. The recall was initiated on 8 Apr 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1261-2019
- FDA event ID
- 82615
- Recalling firm
- Customceutical Compounding, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Apr 2019
- FDA classified
- 30 Apr 2019
- Reported
- 8 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Apr 2019 | Recall initiated by company | |
| 30 Apr 2019 | Classified by FDA | +22 days |
| 8 May 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of sterility for injectables and solutions intended to be sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Which lots are affected?
Lot #: 02182019@27, Exp 8/02/19
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 82615This product is part of a recall event; the main page for the event is BPlex (Methylcobalamin 1000 Mcg/ML Pyridoxal 5 Phosphate recalled.
More recalls from Customceutical Compounding
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|---|---|---|---|---|---|
| Drug | CLASS II | TriMix Medium (Papaverine HCL 21 mg/mL Phentolamine recalled | Customceutical Compounding | Sterility | Nationwide |
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| Drug | CLASS II | Glutathione 200mg/mL inj recalled by Customceutical Compounding | Customceutical Compounding | Sterility | Nationwide |
| Drug | CLASS II | Lipoplex (Methionine 25 MG/ML Inositol 50 MG/ML Choline recalled | Customceutical Compounding | Sterility | Nationwide |