Amneal Pharmaceuticals of New York, LLC: Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceu

Is my product affected?

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

• Brand LORAZEPAM

Check against the official notice below — it lists the full affected range.

What happened

Amneal Pharmaceuticals is recalling Lorazepam Oral Concentrate, USP 2 mg/mL in 30 mL bottles distributed nationwide because the dropper measurement markings may be reversed, shifted, or missing. The recall affects 136,376 bottles across multiple lot numbers with expiration dates ranging from August 2018 through March 2019.

The specific lot numbers affected are: 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); and 06877003A (exp. 03/2019). The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. Distribution: Nationwide Quantity: 136376 bottles Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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