Recalls / Class II
Class IID-0283-2017
Product
Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/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): 06072016F (07/17/2016), 08112016C (09/18/2016).
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
- 10 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-0283-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.