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.
Reported: March 12, 2025 Initiated: February 17, 2025 #D-0254-2025
Product Description
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.
Details
- Recalling Firm
- Safecor Health, LLC
- Units Affected
- 12390 Oral Syringes
- Distribution
- Nationwide in the USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Safecor Health, LLC. Units affected: 12390 Oral Syringes.
Why was this product recalled? ▼
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 12, 2025. Severity: Moderate. Recall number: D-0254-2025.
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