Reported Feb 28, 2018 · Terminated
Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (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?
7 of 7 products
| # | Product as published |
|---|---|
| 1 | 1g (NDC 58597-8471-1) |
| 2 | 10g (NDC 58597-8471-3) |
| 3 | 25g (NDC 58597-8471-4) |
| 4 | 100g (NDC 58597-8471-6) |
| 5 | 500g (NDC 58597-8471-7) |
| 6 | 1000g (NDC 58597-8471-8) |
| 7 | 5000g (NDC 58597-8471-9), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 031115-3, Exp. 12/24/2019 2 031115-3, Exp. 12/24/2019 3 031115-3, Exp. 12/24/2019; 050815-3, Exp. 04/14/2020 4 010716-1, 010716-6, Exp. 11/10/2018; 030116-4, Exp. 12/04/2018; 031115-2, Exp. 12/24/2019; 060116-9, Exp. 4/28/2019; 080416-1, 080416-4, Exp. 06/05/2019; 080615-4, Exp. 07/29/2020; 112015-6, Exp. 10/7/2018; 121916-7, Exp. 11/10/2018 5 080615-5, Exp. 07/29/2020; 010716-4, 010716-5, Exp. 11/10/2018; 030116-2, Exp. 12/04/2018; 031115-5, Exp. 12/24/2019; 060116-1, 060116-4, 060116-5, Exp. 04/28/2019; 080416-1, 080416-2, exp. 06/05/2019; 112015-1, Exp. 10/07/2018; 121916-2,121916-3, 121916-6, Exp. 11/02/2019 6 112015-5, Exp. 10/07/2018; 010716-1, Exp. 11/10/2018; 030116-3, Exp. 12/04/2018; 010716-1, 010716-2, 010716-3, 010716-8, Exp. 11/10/2018; 030116-1, 030116-3, 030116-4,030116-5, Exp. 12/4/2018; 031115-5, Exp. 12/24/2019; 060116-4, 060116-6, 060116-8, 060116-9, Exp. 04/28/2019; 080416-3, 080416-4, 080416-5, Exp. 06/05/2019; 112015-2, 112015-3, 112015-4,112015-6, 112015-7, Exp. 10/07/2018; 121916-1, Exp. 11/02/2019; 121916-3, 121916-4, 121916-5, 121916-7 121916-8, Exp.11/02/2019 7 060116-2, 060116-3 060116-7, Exp. 04/28/2019. - Amount recalled
- 1,050,000 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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