FDA Recall D-0120-2018

Amneal Pharmaceuticals of New York, LLC · Brookhaven, NY

Class I — life-threatening Terminated 1861 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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

Lot / code: 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.

Quantity: 136376 bottles

Reason for recall

Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.

Recall record

Recall number: D-0120-2018
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2017-08-03
Classified by FDA Center: 2017-12-20
FDA published: 2017-12-27
Terminated: 2022-09-07
Recalling firm: Amneal Pharmaceuticals of New York, LLC
Firm location: Brookhaven, NY

Drug identification

Brand name(s): LORAZEPAM
Generic name(s): LORAZEPAM
Manufacturer(s): Amneal Pharmaceuticals LLC
NDC(s): 65162-687
Route(s): ORAL

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