Drug 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.
D-0252-2025
Product summary
- Event
- Event 96308
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1535 Oral Syringes
- Official record key
drug-enforcement:D-0252-2025
Official wording
Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Code information: 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.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.