Reported Feb 28, 2018 · Terminated
Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC…
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?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 5g (NDC 58597-8538-2) |
| 2 | 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6) |
| 3 | 500g (NDC 58597-8538-7) |
| 4 | 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 020717-3, Exp. 12/31/2021 2 020717-2 020717-4, 020717-5 Exp. 12/31/2021; 092816-2, 092816-3, Exp. 07/31/2021; 121015-4, 121015-5, 121015-6, Exp.10/31/2020 3 020717-1, 020717-4, 020717-5, Exp. 12/31/2021; 092816-1, Exp. 07/31/2021; 092816-2, Exp. 07/31/2021; 121015-1,121015-3, Exp. 10/31/2020 4 020717-1, 020717-2, Exp. 12/31/2021; 092816-1, Exp. 07/31/2021; 121015-2, Exp. 10/31/2020 5 020717-1,020717-2 Exp. 12/31/2021. - Amount recalled
- 90000 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new American Pharmaceutical Ingredients LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.