Status
Ongoing
Drug Enforcement D-0252-2025
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
- Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059.
- Product quantity
- 1535 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-0252-2025
- Event ID
- 96308
- Recall initiation date
- February 17, 2025
- Center classification date
- March 5, 2025
- Code info
- Lot #s: a) 24250093, Exp 03/07/2025; 24321592, Exp 04/04/2025; 24280320, Exp 03/27/2025; b) 24371268, Exp 04/19/2025; c) 24400519, Exp 04/07/2025; 24500768, Exp 06/24/2025; 25040972, Exp 07/25/2025.
- More code info
- —