CLASS II Drug recall · Reported 16 May 2018 · FDA Enforcement Report
Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc recalled
Vitalab Pharmacy is recalling Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc, distributed nationwide in the US. The recall was initiated on 24 Apr 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0729-2018
- FDA event ID
- 80000
- Recalling firm
- Vitalab Pharmacy, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2018
- FDA classified
- 9 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Apr 2018 | Recall initiated by company | |
| 9 May 2018 | Classified by FDA | +15 days |
| 16 May 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Where it was distributed
The recalled product was distributed to patients throughout the United States.
Questions about this recall
Is Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc recalled?
Yes. Vitalab Pharmacy recalled Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc on 24 Apr 2018. The recall is Class II and its status is Terminated. Recall number D-0729-2018.
Why was it 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.
Which lots are affected?
Lot #: 02122018@77, Exp 05/13/2018
Where was it sold?
The recalled product was distributed to patients throughout the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Vitalab Pharmacy
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL recalled | Vitalab Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Papaverine 9mg/Phentolamine 1mg/Atropine 1mg/Prostaglandinl recalled | Vitalab Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin recalled | Vitalab Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Papaverine 30mg/Phentolamine 5mg/Prostaglandin 50mcg/mL recalled | Vitalab Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin for injection, 1mg/mL and 10 mg/mL recalled | Vitalab Pharmacy | Sterility | Nationwide |