Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Presence of Foreign Tablets/Capsules
Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Reason Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
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