20 FDA recalls mention Ferrous. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ferrous.
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.
Reason Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Reason cGMP Deviations: Products may have microbial contamination.
Reason cGMP Deviations: Products may have microbial contamination.
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Reason Presence of Foreign Tablets/Capsules
Reason Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on…
Reason Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated…
Reason Subpotent Drug; Ethinyl Estradiol
Reason Subpotent Drug; Ethinyl Estradiol
Reason Subpotent Drug; Ethinyl Estradiol
Reason Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) may be potentially mislabeled as RAMIPRIL, Capsule, 2.5 mg, NDC…
Reason Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC…
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Reason Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
Reason Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
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