Reported Feb 28, 2018 · Terminated
Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (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?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6) |
| 2 | 500g (NDC 58597-8004-7) |
| 3 | 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327. |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 021816-2, 021816-3, Exp. 08/24/2018; 70616-1, Exp. 01/31/2019 2 021816-1, Exp. 08/24/2018; 070616-1, Exp. 01/31/2019 3 021816-1, Exp. 08/24/2018; 070616-1, Exp. 01/31/2019 4 021816-1, Exp. 08/24/2018; 070616-1, exp. 01/31/2019. - Amount recalled
- 55500 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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