FDA-Drug2025-03-12Class II
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.
Safecor Health, LLC
Hazard
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Sold states
Nationwide in the USA
Affected count
12390 Oral Syringes
Manufactured in
4060 Business Park Dr Ste B, Columbus, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0254-2025Don't want to check this manually?
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