Reported Feb 28, 2018 · Terminated
Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); 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 | 100g (NDC 58597-8120-6) |
| 2 | 500g (NDC 58597-8120-7) |
| 3 | 1000g (NDC 58597-8120-8) |
| 4 | 5000g (NDC 58597-8120-9) |
| 5 | 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 |
- Lot codes and dates
Lot #: b) 030816-1Exp. 05/20/2018c) 030816-1Exp. 05/20/2018d) 030816-3Exp. 05/20/2018e) 030816-2Exp. 05/20/2018
- Amount recalled
- 200000 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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