FDAFDA · Food and drugs·Recall number D-0484-2018
Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597-8012-7); d) 1000g (NDC 58597-8012-8), 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) 082715-1, Exp. 06/24/2018; 061715-1, Exp. 6/6/2018; 072516-2, Exp. 07/04/2019; b) 082715-1, Exp. 06/24/2018; 061715-1, Exp. 6/6/2018; 072516-2, Exp. 07/04/2019; c) 061715-1, Exp. 6/6/2018; 072516-2, Exp. 07/04/2019; 082715-1, Exp. 06/24/2018; d) 072516-1, Exp. 07/04/2019; 082715-1, Exp. 06/24/2018;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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