VILAMIT MB 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 VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and…
- Recall number
- D-1487-2020
- 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
VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate), Rx Only, 100 Capsules per Bottle, Manufactured for: Vilvet Pharmaceuticals Inc., Chester Springs, PA 18425, NDC 71186-002-35.
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