Morphine Sulfate USP Milled recalled over sterility concerns
- Recall date
- March 5, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Johnson Matthey Inc. recalls Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003…
- Recall number
- D-1077-2019
- FDA classification
- Class II
- Brand / firm
- Johnson Matthey Inc.
- Sold / distributed
- Nationwide in the US
Why it was recalled
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
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