FDAFDA · Food and drugs·Recall number D-0519-2018
Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), 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) 021317-4, Exp. 12/31/2021; b) 021317-2R, 021317-4, Exp. 12/31/2021; 050115-4, Exp. 3/31/2020; 101915-5, Exp. 08/31/2020 c) 050115-3, 050115-4, Exp. 03/31/2020; d) 021317-3R, Exp 12/31/2021; 050115-2, 050115-3, Exp. 03/31/2020; 101915-3, 101915-4,101915-5, Exp. 08/31/2020; e) 021317-2R, Exp. 12/31/2021; 050115-2, exp. 03/31/2020; 101915-1, 101915-2,101915-5, Exp. 08/31/2020; f) 021317-1R, 021317-2R,021317-3R, Exp. 12/31/2021; 050115-1, 050115-2, Exp. 03/31/2020; 101915-1, 101915-2, Exp. 08/31/2020.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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