Drug 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
D-0120-2018
Product summary
- Event
- Event 77898
- Status
- Terminated
- Classification
- Class I
- Quantity
- 136376 bottles
- Official record key
drug-enforcement:D-0120-2018
Official wording
Reason: Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Code information: 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.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.