Class II · Moderate risk
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.
Iron Special 5ml Mdv 60/10mg/5mcg/Ml Inj
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx only, 5mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Drug: Iron
- Recalling firm
- Key Pharmacy and Compounding Center
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0764-2017 · FDA notice
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.
Other Iron recalls
See all
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Ferrous Sulfate Iron Supplement Drops
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by Key Pharmacy and Compounding Center
All 2017 recalls
Class II · Moderate risk
Vitamin D3 in Olive Oil Sdv 100
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Vitamin D3 in Olive Oil Sdv 100
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Vitamin B Complex 1ml Sdv Na Inj
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Testost Aq Mdv 50mg/Ml Inj
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
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