Vilvet Pharmaceuticals Recalls VILEVEV MB Urinary Antiseptic Due to cGMP Deviations
Vilvet Pharmaceuticals is voluntarily recalling 1,716 bottles of VILEVEV MB Urinary Antiseptic due to current Good Manufacturing Practice (cGMP) deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is a voluntary, firm-initiated action due to cGMP deviations without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Vilvet Pharmaceuticals, Inc. is voluntarily recalling 1,716 bottles of VILEVEV MB Urinary Antiseptic. The product is a prescription-only medication containing methenamine, sodium phosphate monobasic, methylene blue, hyoscyamine sulfate, and phenyl salicylate. The recall was initiated on July 24, 2020, and the product was distributed nationwide within the United States.
The recall was issued due to current Good Manufacturing Practice (cGMP) deviations. The affected lots are M823J18-1, M823J18-2, and M823J18-3 with an expiration date of 09/20, and lot M823D19-1 with an expiration date of 04/21. The FDA classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance on what to do with the medication. The recall was terminated on January 21, 2022.
The recalled product
- Product
- 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
- Manufacturer
- Vilvet Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,716
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- LOT M823J18-1
- M823J18-2
- M823J18-3 EXP 09/20
- LOT M823D19-1 EXP 04/21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Vilvet Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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