FDAFDA · Food and drugs·Recall number D-0493-2018
Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Published February 28, 2018 · Recall initiated: February 9, 2018
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
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Distributor
- Nationwide within USA.
- Lot
- Lot #: a) 062915-2, Exp. 04/30/2020; b) 022416-1, Exp. 11/30/2020; 062915-2, exp. 04/30/2020; 081215-2, Exp. 06/30/2020; c) 022416-1, Exp. 11/30/2020; 062915-1, Exp. 04/30/2020; 081215-1, Exp. 06/30/2020; d) 022416-1, Exp. 11/30/2020; 062915-1, Exp. 04/30/2020; 081215-1, Exp. 06/30/2020; 110415-1, Exp. 09/30/20120
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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