Status
Ongoing
Drug Enforcement D-0254-2025
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Classification
Class II
Report Date
March 12, 2025
Termination Date
—
Product Information
- 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.
- Product quantity
- 12390 Oral Syringes
- Reason for recall
- Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Safecor Health, LLC
- Address
-
4060 Business Park Dr Ste B
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0254-2025
- Event ID
- 96308
- Recall initiation date
- February 17, 2025
- Center classification date
- March 5, 2025
- Code info
- Lot #s: a) 24220672, Exp 02/19/2025; 24280145, Exp 03/18/2025; 24240711, Exp 03/19/2025; b) 24180729, Exp 01/23/2025; 25030427, Exp 07/17/2025; c) 24360865, 24360864, Exp 03/31/2025; 24480235, Exp 06/21/2025.
- More code info
- —