HIGHRegulatoryTier 1
Fresenius Kabi Issues Voluntary Nationwide Recall of One Lot of Morphine Sulfate Injection, USP in a Simplist® Prefilled Syringe Due to Labeling Mix-up
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dental practices that stock or administer morphine sulfate for in-office sedation or post-op pain must immediately quarantine lot 651112, because a mis-labeled syringe could deliver the wrong drug or dose, exposing the dentist to liability and licensing risk.
Key points
- Lot 651112 of Fresenius Kabi Simplist® Morphine Sulfate 2 mg/1 mL (NDC 63323-0412-00) is under voluntary recall for a label mix-up that could result in the wrong medication in the syringe.
- Recalled units bear a MicroVault label reading "Morphine 2 mg/1 mL" but may contain a different prefilled syringe product.
- Dentists, oral surgeons, and staff who purchase controlled-substance prefilled syringes should check inventory immediately and quarantine any lot 651112 units.
- Product should not be administered; contact Fresenius Kabi at 1-800-551-7176 for return instructions and replacement.
Who should care
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Read the original on FDA Recalls
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