FDAHealthFebruary 17, 2025
Safecor Health, LLC — 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) 3932
⚠️ Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 17, 2025
Nationwide in the USA
What's affected?
- Product
- 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.
- Brand
- Safecor Health, LLC
- Lot code
- a)
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1535 Oral Syringes.
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