FDAFDA · Food and drugs·Recall number D-0120-2018
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84
Published December 27, 2017 · Recall initiated: August 3, 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
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LORAZEPAM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- Nationwide
- Lot
- Lot 06876016A, 06876017A, 06876018A, Exp 08/2018; 06876019A, 06876020A, 06876021A, 06876022A, Exp 09/2018; 06876023A, Exp 11/2018; 06876024A, 06876025A, Exp 12/2018; 06877001A, 06877002A, Exp 02/2019; 06877003A, Exp 03/2019.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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