CLASS II ONGOING Drug recall · Reported 11 Jan 2017 · FDA Enforcement Report
TriMix, Alprostadil/Phentolamine/Papaverine recalled
Tri-Coast Pharmacy is recalling TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL. Compounded by Tri-Coast, distributed nationwide in the US. The recall was initiated on 17 Nov 2016 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-0315-2017
- FDA event ID
- 75763
- Recalling firm
- Tri-Coast Pharmacy, Juno Beach, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Nov 2016
- FDA classified
- 4 Jan 2017
- Reported
- 11 Jan 2017
- 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
- Compounded Drugs
Timeline
| 17 Nov 2016 | Recall initiated by company | |
| 4 Jan 2017 | Classified by FDA | +48 days |
| 11 Jan 2017 | Published in enforcement report | +7 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
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, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016E (07/07/2016), 06092016C (07/17/2016), 05022016E (05/22/2016), 06232016D (08/04/2016), 06202016B (07/17/2016), 06152016E (07/17/2016), 06082016E (07/17/2016), 06022016C (07/17/2016), 07282016F (09/08/2016), 07262016G (09/04/2016), 07222016D (09/04/2016), 07192016D (09/01/2016), 07152016F (08/22/2016), 07082016C (08/22/2016), 08292016C (09/29/2016), 08052016C (09/16/2016), 08042016H (09/18/2016), 08022016E (09/16/2016), 09272016C (11/06/2016), 11012016B (12/09/2016), 05192016B (07/03/2016), 06132016F (07/17/2016), 06292016D (08/04/2016), 06222016E (08/04/2016), 06162016B (07/31/2016), 06132016C (07/17/2016), 06072016D (07/17/2016), 06012016D (07/16/2016), 07222016E (09/04/2016), 07202016A (09/01/2016), 07182016C (09/01/2016), 07132016B (08/22/2016), 07062016E (08/04/2016), 08092016F (09/18/2016), 08042016J (09/06/2016), 08032016D (09/16/2016), 09072016D (09/29/2016), 10132016C (11/24/2016).
Where was it sold?
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
79 other products · FDA event 75763This product is part of a recall event; the main page for the event is TriMix, Alprostadil/Phentolamine/Papaverine recalled.
More recalls from Tri-Coast Pharmacy
All 80| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amino Energy Cocktail, (Methionine recalled by Tri-Coast Pharmacy | Tri-Coast Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Amino Acid Recover Eaze, Phenylaline (L) 8 mg/ml + Tyrosine recalled | Tri-Coast Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | HCG 5,000 IU Vial recalled by Tri-Coast Pharmacy | Tri-Coast Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | HCG 11,000 IU Vial recalled by Tri-Coast Pharmacy | Tri-Coast Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | L-Arginine HCL 100 mg/mL. Compounded by Tri-Coast Pharmacy recalled | Tri-Coast Pharmacy | 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 30mg/1 mg/10mcg/mL ( 30 mg Papaverine recalled | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | TriMix, Alprostadil/Phentolamine/Papaverine recalled | Tri-Coast Pharmacy | Sterility | Nationwide |