Why it was recalled
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Product description
Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05
Lot numbers, UPCs & expiration codes
Lot Code: 20151305@17 BUD: 9/16/2015, 20151504@18 BUD: 9/16/2015, 20151903@13 BUD: 9/12/2015, 20151903@13 BUD: 9/12/2015, 20152107@3 BUD: 1/16/2016, 20152204@6 BUD: 9/16/2015, 20152403@13 BUD: 9/12/2015, 20152403@21 BUD: 9/16/2015, 20152904@8 BUD: 9/16/2015
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-0288-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 12, 2015
- FDA report date
- Nov 25, 2015
- Quantity
- 797 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- US Compounding Inc
Original FDA data
Every field from FDA enforcement report D-0288-2016, exactly as published.
Show all FDA fields
- City
- Conway
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 72179
- Address
- 1270 Don's Lane
- Code information
- Lot Code: 20151305@17 BUD: 9/16/2015, 20151504@18 BUD: 9/16/2015, 20151903@13 BUD: 9/12/2015, 20151903@13 BUD: 9/12/2015, 20152107@3 BUD: 1/16/2016, 20152204@6 BUD: 9/16/2015, 20152403@13 BUD: 9/12/2015, 20152403@21 BUD: 9/16/2015, 20152904@8 BUD: 9/16/2015
- Postal code
- 72032
- Report date
- Nov 25, 2015
- Product type
- Drugs
- Recall number
- D-0288-2016
- Classification
- Class II
- Recalling firm
- US Compounding Inc
- Product quantity
- 797 vials
- Termination date
- Mar 30, 2017
- Reason for recall
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 12, 2015
- Initial firm notification
- Letter
- Center classification date
- Nov 17, 2015