Reported Feb 28, 2018 · Terminated
Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6);…
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 58597-8012-4); b)100g (NDC 58597-8012-6) |
| 2 | 500 g (NDC 58597-8012-7) |
| 3 | 1000g (NDC 58597-8012-8), 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 082715-1, Exp. 06/24/2018; 061715-1, Exp. 6/6/2018; 072516-2, Exp. 07/04/2019 2 082715-1, Exp. 06/24/2018; 061715-1, Exp. 6/6/2018; 072516-2, Exp. 07/04/2019 3 061715-1, Exp. 6/6/2018; 072516-2, Exp. 07/04/2019; 082715-1, Exp. 06/24/2018 4 072516-1, Exp. 07/04/2019; 082715-1, Exp. 06/24/2018 - Amount recalled
- 116850 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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