Drug 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.
D-0253-2025
Product summary
- Event
- Event 96308
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3465 Oral Syringes
- Official record key
drug-enforcement:D-0253-2025
Official wording
Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
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.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.