Oxaliplatin Active Pharmaceutical Ingredient recalled over manufacturing violations
- Recall date
- August 29, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Johnson Matthey Inc. recalls Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford,…
- Recall number
- D-1882-2019
- FDA classification
- Class II
- Brand / firm
- Johnson Matthey Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
cGMP Deviations: Potential glass contamination
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX
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