Status
Ongoing
Drug Enforcement D-0253-2025
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Classification
Class II
Report Date
March 12, 2025
Termination Date
—
Product Information
- 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.
- Product quantity
- 3465 Oral Syringes
- Reason for recall
- Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Safecor Health, LLC
- Address
-
4060 Business Park Dr Ste B
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0253-2025
- Event ID
- 96308
- Recall initiation date
- February 17, 2025
- Center classification date
- March 5, 2025
- Code info
- 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.
- More code info
- —