Reported Feb 28, 2018 · Terminated
Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (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?
6 of 6 products
| # | Product as published |
|---|---|
| 1 | 500mg (NDC 58597-8142-1) |
| 2 | 1g (NDC 58597-8056-2) |
| 3 | 5g (NDC 58597-8056-3) |
| 4 | 10g (NDC 58597-8056-4) |
| 5 | 25 g (NDC 58597-8056-4) |
| 6 | 100g (NDC 58597-8056-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 b) 012216-1, Exp. 12/31/2019; 051515-3, Exp. 02/28/2019; 051515-3, Exp. 02/28/2019 2 012216-1, Exp. 12/31/2019; 051515-3, Exp. 02/28/2019 3 012216-1, Exp. 12/31/2019; 051515-2, Exp. 02/28/2019; 061516-1, Exp. 01/31/2020 4 051515-2, exp. 02/28/2019; 061516-1, Exp. 01/31/2020; ; 082117A-1, Exp. 05/31/2021 5 012216-1, Exp. 12/31/2019; 051515-1, Exp. 02/28/2019; 061516-1, Exp. 01/31/2020; ; 082117A-1, Exp. 05/31/2021 - Amount recalled
- 10769 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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