Class II · Moderate risk Ongoing
Hippiron 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
53 FDA recalls mention Iron. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Iron.
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Reason Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
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