Premier Dental Products Co. is recalling 573 cartons of Monsel's Ferric Subsulfate Solution (8 mL bottles) because the expiration date on the individual vials is printed incorrectly. The labels show an extra digit, displaying '2709114' instead of the correct date of September 14, 2027 (270914). While the outer box of 12 bottles has the correct date, the error on the internal vials could lead to confusion regarding the product's shelf life.
The incorrect expiration date printed on the vial may cause healthcare providers to misinterpret the product's stability or validity, though the solution itself remains safe for use until its actual expiration in September 2027. No injuries or incidents have been reported.
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The expiration date is printed as 2709114 instead of the correct 270914 on the vial. The box of 12 bottles has the correct date.
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Sources: FDA iRES · Raw API Response
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