IRON SPECIAL MDV 60/10MG/5MCG/ML INJ recalled over sterility concerns
- Recall date
- April 18, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Key Pharmacy and Compounding Center recalls IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx only, 5mL Glass /Multiple Dose vial, Prepared…
- Recall number
- D-0764-2017
- FDA classification
- Class II
- Brand / firm
- Key Pharmacy and Compounding Center
- Sold / distributed
- Distributed nationwide in U.S.A., Australia and Canada.
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
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
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