FDAFDA · Food and drugs·Recall number D-0197-2018
Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Published January 17, 2018 · Recall initiated: November 16, 2017
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
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- KRS Global Biotechnology, Inc
- Distributor
- Nationwide in the USA, Bermuda, and New Zealand
- Lot
- Lot: 07052017@2 BUD: 1/1/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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