Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP Deviations: Products may have microbial contamination.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 52807-177-16
Compare with the code on your package — it is the most precise check available.
Drug: Iron
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Presence of Particulate Matter: Potential for glass delamination from the vials.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
cGMP Deviations: Products may have microbial contamination.
cGMP Deviations: Products may have microbial contamination.
cGMP Deviations: Products may have microbial contamination.
cGMP Deviations: Products may have microbial contamination.
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