Recalls / Class II
Class IID-0311-2017
Product
TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
- Affected lot / code info
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05132016A (07/07/2016), 07212016A (09/01/2016), 07292016B (09/08/2016), 08012016F (09/08/2016), 09072016C (09/27/2016), 11012016C (12/09/2016), 05182016E (07/02/2016), 09012016C (09/29/2016), 09272016H (11/06/2016).
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Tri-Coast Pharmacy
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 14125 US Highway 1, N/A, Juno Beach, Florida 33408-1425
Distribution
- Quantity
- 35 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-17
- FDA classified
- 2017-01-04
- Posted by FDA
- 2017-01-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0311-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.