FDAFDA · Food and drugs·Recall number D-0245-2016
Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07
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: 20152707@22 BUD: 10/25/2015; 20150707@9 BUD: 10/5/2015; 20152906@15 BUD: 9/27/2015; 20152907@2 BUD: 10/27/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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