Why it was recalled
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Product description
PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Lot numbers, UPCs & expiration codes
Lot #: 20140901@3, discard date: 10/19/2014
Where it was sold
Oregon, Washington
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-0212-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 6, 2014
- FDA report date
- Nov 12, 2014
- Quantity
- 10 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Oregon Compounding Centers, Inc. dba Creative Compounds
Original FDA data
Every field from FDA enforcement report D-0212-2015, exactly as published.
Show all FDA fields
- City
- Wilsonville
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 69519
- Address
- 8560 Sw Salish Ln Ste 100
- Code information
- Lot #: 20140901@3, discard date: 10/19/2014
- Postal code
- 97070-9625
- Report date
- Nov 12, 2014
- Product type
- Drugs
- Recall number
- D-0212-2015
- Classification
- Class II
- Recalling firm
- Oregon Compounding Centers, Inc. dba Creative Compounds
- Product quantity
- 10 mL
- Termination date
- Jun 30, 2015
- Reason for recall
- Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
- Distribution pattern
- Oregon, Washington
- Recall initiation date
- Oct 6, 2014
- Initial firm notification
- Press Release
- Center classification date
- Oct 31, 2014