CLASS II Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine recalled
Pharm D Solutions is recalling Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg, distributed nationwide in the US. The recall was initiated on 23 May 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-1339-2019
- FDA event ID
- 82941
- Recalling firm
- Pharm D Solutions, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2019
- FDA classified
- 7 Jun 2019
- Reported
- 19 Jun 2019
- Type
- FDA Mandated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 23 May 2019 | Recall initiated by company | |
| 7 Jun 2019 | Classified by FDA | +15 days |
| 19 Jun 2019 | Published in enforcement report | +12 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 Sterility Assurance.
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 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Sterility Assurance.
Which lots are affected?
Lot #: 05022019:90 Exp. 07/13/2019
Where was it sold?
Nationwide within the United States
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
17 other products · FDA event 82941This product is part of a recall event; the main page for the event is Human Chorionic Gonadotropin 5,000 IU vials recalled.
More recalls from Pharm D Solutions
All 100| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Human Chorionic Gonadotropin 10,000 IU vials recalled | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Nandrolone Decanoate 200 mg/mL Injectable vials recalled | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Sermorelin/Ghrp-2 & 6 (3-3-3 MG) vials recalled by Pharm D Solutions | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | B-complex (Thiamine 100mg, Riboflavin 2mg recalled by Pharm D Solutions | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Sermorelin/Ghrp-2 9 mg/9 mg vials Pharm D. Solutions recalled | Pharm D Solutions | Sterility | Nationwide |
Other Trimix recalls
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) recalled | Northern VA Compounders Pllc | Sterility | Nationwide |
| Drug | CLASS II | TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine recalled | Northern VA Compounders Pllc | Sterility | Nationwide |
| Drug | CLASS II | Trimix 30MG/1MG/10MCG/ML INJ in vials Assurance Infusion recalled | Assurance Infusion | Sterility | Nationwide |
| Drug | CLASS II | TriMix, Alprostadil/Phentolamine/Papaverine recalled | Tri-Coast Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Trimix Injectable 30 mg/3 mg/60 mcg/mL, a), b) and c) vials recalled | Wells Pharmacy Network | Sterility | Nationwide |