Reported Feb 28, 2018 · Terminated
Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); 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?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 25g (NDC 58597-8333-4) |
| 2 | 100g (NDC 58597-8333-6) |
| 3 | 500g (NDC 58597-8333-7) |
| 4 | 1000g (NDC 58597-8333-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 102015-3, Exp. 07/31/2020; 081616-3R, Exp. 02/28/2021 2 081616-3, 081616-3R, Exp. 02/28/2021; 102015-2, Exp. 07/31/2020 3 081616-1R, Exp. 02/28/2021; 081616-1, Exp. 02/29/2021; 102015-1, 102015-2, Exp. 07/31/2020 4 102015-1, Exp. 07/31/2020; 081616-1, Exp. 02/29/2021; 081616-1R, 081616-2R, Exp. 02/28/2021. - Amount recalled
- 191000 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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