Reported May 16, 2018 · Terminated
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine…
Vitalab Pharmacy, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vitalab Pharmacy, Inc · 4045 E Bell Rd Ste 163 · Phoenix, AZ · 85032-2240
Is this the product you have?
- Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable
- ST3Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc
- Lot codes and dates
- Lot #: 03052018@54
- Amount recalled
- N/A
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
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.
This product could cause temporary or reversible health problems — stop using it.
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