FDA Drug recall D-0120-2018
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876
- FDA Drug
- Class I
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class I recall of Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876 by Amneal Pharmaceuticals, citing defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0120-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-08-03 |
| Published | 2017-12-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
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
Reason
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Identifiers
| ndc | 65162-687-84 |
|---|---|
| code_info | Lot 06876016A, 06876017A, 06876018A, Exp 08/2018; 06876019A, 06876020A, 06876021A, 06876022A, Exp 09/2018; 06876023A, E…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0120-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.