Reported Feb 28, 2018 · Terminated
Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (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 | 1g (NDC 58597-8407-1) |
| 2 | 5g (NDC 58597-8407-2) |
| 3 | 25g (NDC 58597-8407-4) |
| 4 | 100g (NDC 58597-8407-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 |
- Lot codes and dates
Lot #: a) 120916-1Exp. 10/31/2019b) 120916-1Exp. 10/31/2019 c) 120916-1Exp. 10/31/2019d) 120916-1Exp. 10/31/2019
- Amount recalled
- 7000 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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