FDAFDA · Food and drugs·Recall number D-0537-2018
Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8056-2); c) 5g (NDC 58597-8056-3); d) 10g (NDC 58597-8056-4), e) 25 g (NDC 58597-8056-4); f) 100g (NDC 58597-8056-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Published February 28, 2018 · Recall initiated: February 9, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Distributor
- Nationwide within USA.
- Lot
- Lot #: a) b) 012216-1, Exp. 12/31/2019; 051515-3, Exp. 02/28/2019; 051515-3, Exp. 02/28/2019; c) 012216-1, Exp. 12/31/2019; 051515-3, Exp. 02/28/2019 d) 012216-1, Exp. 12/31/2019; 051515-2, Exp. 02/28/2019; 061516-1, Exp. 01/31/2020; e) 051515-2, exp. 02/28/2019; 061516-1, Exp. 01/31/2020; ; 082117A-1, Exp. 05/31/2021; f) 012216-1, Exp. 12/31/2019; 051515-1, Exp. 02/28/2019; 061516-1, Exp. 01/31/2020; ; 082117A-1, Exp. 05/31/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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