VILEVEV MB Urinary Antispetic recalled over manufacturing violations
- Recall date
- July 24, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Vilvet Pharmaceuticals Inc. recalls VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12…
- Recall number
- D-1488-2020
- FDA classification
- Class II
- Brand / firm
- Vilvet Pharmaceuticals Inc.
- Sold / distributed
- Nationwide within the US
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
VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate), Rx Only, 90 Tablets per Bottle, Manufactured for: Vilvet Pharmaceuticals, Inc., Chester Springs, PA 19425, NDC 71186-000-24.
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