Why it was recalled
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Product description
Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Lot numbers, UPCs & expiration codes
Lot 04022015:93@10, expiry date: 7/31/2015;
Where it was sold
MT and ND
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-1118-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 15, 2015
- FDA report date
- Jun 17, 2015
- Quantity
- 1/5 mL vial
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Montana Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-1118-2015, exactly as published.
Show all FDA fields
- City
- Missoula
- State
- MT
- Status
- Terminated
- Country
- United States
- Event ID
- 71275
- Address
- 111 N Higgins Ave
- Code information
- Lot 04022015:93@10, expiry date: 7/31/2015;
- Postal code
- 59802-4437
- Report date
- Jun 17, 2015
- Product type
- Drugs
- Recall number
- D-1118-2015
- Classification
- Class II
- Recalling firm
- Montana Compounding Pharmacy
- Product quantity
- 1/5 mL vial
- Termination date
- Dec 20, 2016
- Reason for recall
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
- Distribution pattern
- MT and ND
- Recall initiation date
- May 15, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 9, 2015