Why it was recalled
Lack of Assurance of Sterility
Product description
Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
Lot numbers, UPCs & expiration codes
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05242016A (07/08/2016).
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0280-2017
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 17, 2016
- FDA report date
- Jan 11, 2017
- Quantity
- 5 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tri-Coast Pharmacy
Original FDA data
Every field from FDA enforcement report D-0280-2017, exactly as published.
Show all FDA fields
- City
- Juno Beach
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 75763
- Address
- 14125 US Highway 1
- Code information
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05242016A (07/08/2016).
- Postal code
- 33408-1425
- Report date
- Jan 11, 2017
- Product type
- Drugs
- Recall number
- D-0280-2017
- Classification
- Class II
- Recalling firm
- Tri-Coast Pharmacy
- Product quantity
- 5 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 17, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jan 4, 2017