Reported Feb 28, 2018 · Terminated
Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c)…
American Pharmaceutical Ingredients LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Pharmaceutical Ingredients LLC · 6650 Highland Rd Ste 302 · Waterford, MI · 48327-1665
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | 5g (NDC 58597-8088-2) |
| 2 | 25g (NDC 58597-8088-4) |
| 3 | 50g (NDC 58597-8088-5) |
| 4 | 100g (NDC 58597-8088-6) |
| 5 | 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 |
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 021317-4, Exp. 12/31/2021 2 021317-2R, 021317-4, Exp. 12/31/2021; 050115-4, Exp. 3/31/2020; 101915-5, Exp. 08/31/2020 3 050115-3, 050115-4, Exp. 03/31/2020 4 021317-3R, Exp 12/31/2021; 050115-2, 050115-3, Exp. 03/31/2020; 101915-3, 101915-4,101915-5, Exp. 08/31/2020 5 021317-2R, Exp. 12/31/2021; 050115-2, exp. 03/31/2020; 101915-1, 101915-2,101915-5, Exp. 08/31/2020 6 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. - Amount recalled
- 307500 g
This recall covers 66 products
The agency filed one notice per product. You are reading one of them; the other 65 are below.
53 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
This product could cause temporary or reversible health problems — stop using it.
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