FDAFDA · Food and drugs·Recall number D-0277-2016
Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3272-03
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 Code: 20150206@3 BUD: 11/29/2015, 20150306@51 BUD: 11/30/2015, 20151106@28 BUD: 12/8/2015, 20151404@4 BUD: 10/11/2015, 20151606@3 BUD: 12/13/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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