Product: Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.
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