Why it was recalled
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Product description
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.
Lot numbers, UPCs & expiration codes
Lot #s: a) 24210274, Exp 01/31/2025; 24401700, Exp 04/25/2025; b) 24251067, Exp 03/25/2025; 24421733, Exp 06/03/2025; c) 24261384, Exp 03/24/2025; 24370127, Exp 04/28/2025.
Where it was sold
Nationwide in the USA
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-0253-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 17, 2025
- FDA report date
- Mar 12, 2025
- Quantity
- 3465 Oral Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Safecor Health, LLC
Original FDA data
Every field from FDA enforcement report D-0253-2025, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 96308
- Address
- 4060 Business Park Dr Ste B
- Code information
- Lot #s: a) 24210274, Exp 01/31/2025; 24401700, Exp 04/25/2025; b) 24251067, Exp 03/25/2025; 24421733, Exp 06/03/2025; c) 24261384, Exp 03/24/2025; 24370127, Exp 04/28/2025.
- Postal code
- 43204-5047
- Report date
- Mar 12, 2025
- Product type
- Drugs
- Recall number
- D-0253-2025
- Classification
- Class II
- Recalling firm
- Safecor Health, LLC
- Product quantity
- 3465 Oral Syringes
- Reason for recall
- Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 17, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 5, 2025