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.
Reason for recall: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiated: 20250217
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated