D-0253-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 12, 2025
- Initiation Date
- February 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3465 Oral 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.
Reason for Recall
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Distribution Pattern
Nationwide in the USA
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.