FDAHealthFebruary 17, 2025
Safecor Health, LLC — 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) 000543
⚠️ Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 17, 2025
Nationwide in the USA
What's affected?
- Product
- 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.
- Brand
- Safecor Health, LLC
- Lot code
- a)
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3465 Oral Syringes.
Get Health recall alerts
Delivered to your inbox. Free. No account required.