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Recall Observatory FDA recall evidence

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

February 17, 2025

Class II

Product summary

Firm
Safecor Health, LLC
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

    reason.no_named_rule · v1.0.0

    Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.