Why it was recalled
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Product description
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 numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0120-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 3, 2017
- FDA report date
- Dec 27, 2017
- Quantity
- 136376 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
Original FDA data
Every field from FDA enforcement report D-0120-2018, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 77898
- Address
- 50 Horseblock Rd
- 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.
- Postal code
- 11719-9509
- Report date
- Dec 27, 2017
- Product type
- Drugs
- Recall number
- D-0120-2018
- Classification
- Class I
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Product quantity
- 136376 bottles
- Termination date
- Sep 7, 2022
- Reason for recall
- Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 3, 2017
- Initial firm notification
- Letter
- Center classification date
- Dec 20, 2017