Reported Feb 28, 2018 · Terminated
Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g…
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 | 25g (NDC 58597-8014-4) |
| 2 | 100g (NDC 58597-8014-6) |
| 3 | 500g (NDC 58597-8014-7) |
| 4 | 1000g (NDC 58597-8014-8), 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 031116-7, exp. 03/31/2019; 112816-1, Exp. 03/01/2020 2 011717-2, 051617-1, Exp. 04/30/2020; 031116-1, 031116-2, 031116-7, exp. 03/31/2019; 051215-1, exp. 03/05/2018; 063015-1, Exp. 05/19/2018; 092315-1, Exp. 07/17/2018; 111615-6, Exp. 08/27/2018; 112816-1, Exp. 03/01/2020 3 011717-7, 011717-2, 051617-1, 082117B-1, Exp. 04/30/2020; ; 031116-2, 031116-4, 031116-5, 031116-7, Exp.. 03/31/2019; 051215-1, Exp. 03/05/2018; 092315-2, Exp. 07/17/2018; 111615-4, 111615-5, Exp. 08/27/2018; 112816-1, 112816-2, Exp. 03/01/2020 4 011717-7, 051617-1, 082117B-1, Exp. 04/30/2020; 031116-1, 031116-2, 031116-3, 031116-4, 031116-6, 031116-7, Exp. 03/31/2019; 051215-1, 051215-3, Exp. 03/05/2018; 063015-2, Exp. 05/19/2018; 111615-1, 111615-2, 111615-3, Exp. 08/27/2018; 112816-2, Exp. 03/01/2020 - Amount recalled
- 606950
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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