Why it was recalled
Lack of Processing Controls
Product description
Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lot numbers, UPCs & expiration codes
Lot #: 6054N; 4796N, Exp 7/16/2019; 7049N, Exp 11/24/2019
Where it was sold
CO, TX, WY
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-1573-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 22, 2019
- FDA report date
- Aug 7, 2019
- Quantity
- 84 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wise Pharmacy
Original FDA data
Every field from FDA enforcement report D-1573-2019, exactly as published.
Show all FDA fields
- City
- Littleton
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 83397
- Address
- 6179 S Balsam Way Ste 150
- Code information
- Lot #: 6054N; 4796N, Exp 7/16/2019; 7049N, Exp 11/24/2019
- Postal code
- 80123-3095
- Report date
- Aug 7, 2019
- Product type
- Drugs
- Recall number
- D-1573-2019
- Classification
- Class II
- Recalling firm
- Wise Pharmacy
- Product quantity
- 84 vials
- Termination date
- Feb 3, 2020
- Reason for recall
- Lack of Processing Controls
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
- Distribution pattern
- CO, TX, WY
- Recall initiation date
- Jul 22, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2019