Vilvet Pharmaceuticals Recalls VILAMIT MB Due to cGMP Deviations
Vilvet Pharmaceuticals is recalling 11,640 bottles of VILAMIT MB capsules due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and nationwide.
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, which typically involves a reasonable probability of temporary or medically reversible health consequences. The source cites cGMP deviations without reporting specific illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Vilvet Pharmaceuticals Inc. is voluntarily recalling 11,640 bottles of VILAMIT MB capsules. The product is a prescription-only medication containing methenamine, phenyl salicylate, sodium phosphate monobasic, methylene blue, and hyoscyamine sulfate. The recall was initiated on July 24, 2020, and is classified as Class II by the FDA.
The reason for the recall is cited as current Good Manufacturing Practice (cGMP) deviations. The affected lots were distributed nationwide within the United States. The specific lot numbers and expiration dates are: M824H18-1 (EXP 08/20), M824J18-1 (EXP 09/20), M824L18-1 (EXP 11/20), M824A19-1 (EXP 01/21), M824C19-1 (EXP 03/21), and M824G19-1 (EXP 07/21).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. The recall status is currently terminated as of January 21, 2022. No specific instructions for disposal or return are provided in the source text, but the firm initiated the recall voluntarily.
The recalled product
- Product
- 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.
- Manufacturer
- Vilvet Pharmaceuticals Inc.
- Category
- Drug — Prescription Capsules
- Hazard
- Affected units
- 11,640
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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