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Class II: temporary or reversible health riskTerminated

Vitalab Pharmacy Alprostadil 20 mcg/mL Recall

Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc

Vitalab Pharmacy, Inc · Phoenix, AZ

Risk level
Class II
Reported by FDA
May 16, 2018
Recall ID
D-0729-2018
Check your lot numberHow we source this data

Summary

Vitalab Pharmacy recalled Alprostadil 20 mcg/mL starting Apr 24, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0729-2018 on May 16, 2018. Reason: Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products. Status: Terminated.

Why it was recalled

Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

Product description

Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc

Lot numbers, UPCs & expiration codes

Lot #: 02122018@77, Exp 05/13/2018

Where it was sold

The recalled product was distributed to patients throughout the United States.

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-0729-2018
Classification
Class II
Status
Terminated
Recall initiated
Apr 24, 2018
FDA report date
May 16, 2018
Quantity
2 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Vitalab Pharmacy, Inc

Original FDA data

Every field from FDA enforcement report D-0729-2018, exactly as published.

Show all FDA fields
City
Phoenix
State
AZ
Status
Terminated
Country
United States
Event ID
80000
Address
4045 E Bell Rd Ste 163
Code information
Lot #: 02122018@77, Exp 05/13/2018
Postal code
85032-2240
Report date
May 16, 2018
Product type
Drugs
Recall number
D-0729-2018
Classification
Class II
Recalling firm
Vitalab Pharmacy, Inc
Product quantity
2 vials
Termination date
Jan 23, 2020
Reason for recall
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Distribution pattern
The recalled product was distributed to patients throughout the United States.
Recall initiation date
Apr 24, 2018
Initial firm notification
Letter
Center classification date
May 9, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0729-2018, published May 16, 2018. 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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