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Class II: temporary or reversible health riskTerminated

Montana Compounding Pharmacy Alprostadil Recall

Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by…

Montana Compounding Pharmacy · Missoula, MT

Risk level
Class II
Reported by FDA
Jun 17, 2015
Recall ID
D-1117-2015
Check your lot numberHow we source this data

Summary

Montana Compounding Pharmacy recalled Alprostadil starting May 15, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1117-2015 on Jun 17, 2015. Reason: Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Product description

Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Lot numbers, UPCs & expiration codes

Lot 03252015:61@6, expiry date: 7/23/2015

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-1117-2015
Classification
Class II
Status
Terminated
Recall initiated
May 15, 2015
FDA report date
Jun 17, 2015
Quantity
1/5mL vial
Recall type
Voluntary: Firm initiated
Recalling firm
Montana Compounding Pharmacy

Original FDA data

Every field from FDA enforcement report D-1117-2015, 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 03252015:61@6, expiry date: 7/23/2015
Postal code
59802-4437
Report date
Jun 17, 2015
Product type
Drugs
Recall number
D-1117-2015
Classification
Class II
Recalling firm
Montana Compounding Pharmacy
Product quantity
1/5mL 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, 10 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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1117-2015, published Jun 17, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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