Desoximetasone USP for prescription compounding recalled over manufacturing violations
- Recall date
- February 9, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- American Pharmaceutical Ingredients LLC recalls Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredient…
- Recall number
- D-0483-2018
- FDA classification
- Class II
- Brand / firm
- American Pharmaceutical Ingredients LLC
- Sold / distributed
- Nationwide within USA.
Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2.
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