Class I · Most seriousRecall completed
Lorazepam
A reasonable chance it could cause serious harm or death.
Does this affect you?
Check your lot numberLot 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.
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAmneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141
| Brand name | LORAZEPAM |
| Generic name | LORAZEPAM |
| Active ingredient(s) | LORAZEPAM |
| Distributed by / for | Amneal Pharmaceuticals, Glasgow, KY 42141 |
| NDC | 65162-687-84 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC |
| Distribution | Nationwide |
| Quantity | 136376 bottles |
| Recall initiated | 2017-08-03 |
| Report date | 2017-12-27 |
| Recall completed | 2022-09-07 |
| Recall number | D-0120-2018 |
| Classification | Class I |
| FDA status | Terminated |
| Origin on file | Brookhaven NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.