FDAFDA · Food and drugs·Recall number D-0237-2016
Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC: 62295-3253-05.
Published November 25, 2015 · Recall initiated: September 12, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- US Compounding Inc
- Distributor
- Nationwide
- Lot
- Lot Numbers: 20150408@10 BUD: 1/27/2015; 20151407@11 BUD: 1/10/2015; 20151604@8 9/16/2015; 20152703@2 9/16/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States