Loxapine Capsules recalled over manufacturing violations
- Recall date
- April 24, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Mylan Pharmaceuticals Inc. recalls Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
- Recall number
- D-0824-2018
- FDA classification
- Class II
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- Product was distributed throughout the United States, including Puerto Rico.
Why it was recalled
CGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
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