Medications & Supplements/Prescription Drugs

Vilvet Pharmaceuticals Inc.: VILAMIT MB and VILEVEV MB Recalled for Manufacturing Deviations

Agency Publication Date: August 6, 2020

Summary

Vilvet Pharmaceuticals Inc. is recalling 13,356 bottles of VILAMIT MB (118 mg methenamine/36 mg phenyl salicylate/40.8 mg sodium phosphate monobasic/10.0 mg methylene blue/0.12 mg hyoscyamine sulfate) and VILEVEV MB Urinary Antispetic (81.0 mg methenamine/40.8 mg sodium phosphate monobasic/10.8 mg methylene blue/0.12 mg hyoscyamine sulfate/32.4 mg phenyl salicylate). These prescription medications were recalled because they were not manufactured according to current Good Manufacturing Practice (cGMP) standards. This means the products may not meet quality or safety requirements, which could impact their performance or purity. These medications were distributed across the United States to healthcare facilities and pharmacies.

Risk

Failure to follow standard manufacturing practices can lead to inconsistent medication quality, potentially resulting in drugs that are ineffective or contaminated. This poses a health risk to patients who depend on these medications for urinary conditions.

What You Should Do

Check your prescription bottles for VILAMIT MB (100 Capsules per Bottle, NDC 71186-002-35) or VILEVEV MB Urinary Antispetic (90 Tablets per Bottle, NDC 71186-000-24).
Inspect the label for the following VILAMIT MB lot numbers and expiration dates: 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), or M824G19-1 (Exp 07/21).
Inspect the label for the following VILEVEV MB lot numbers and expiration dates: M823J18-1, M823J18-2, or M823J18-3 (all Exp 09/20), and M823D19-1 (Exp 04/21).
If your medication is part of this recall, contact your healthcare provider or pharmacist immediately to discuss alternative treatment and stop using the affected lot.
Return any unused product to the pharmacy or place of purchase for a full refund.
Contact Vilvet Pharmaceuticals Inc. at their distributor address (1208 Kimberton Rd Ste 101, Chester Springs, PA) for further instructions on returning the product.
For additional information, contact the FDA Consumer Complaint line at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Refund for unused medication.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: VILAMIT MB (100 Capsules per Bottle)

Model:

NDC 71186-002-35

Lot Numbers:

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)

M824G19-1 (Exp 07/21)

Date Ranges: August 2020, September 2020, November 2020, January 2021, March 2021, July 2021

Product: VILEVEV MB Urinary Antispetic (90 Tablets per Bottle)

Model:

NDC 71186-000-24

Lot Numbers:

M823J18-1 (Exp 09/20)

M823J18-2 (Exp 09/20)

M823J18-3 (Exp 09/20)

M823D19-1 (Exp 04/21)

Date Ranges: September 2020, April 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86069

Status: Resolved

Manufacturer: Vilvet Pharmaceuticals Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (11,640 bottles; 1,716 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your prescription bottles for VILAMIT MB (100 Capsules per Bottle, NDC 71186-002-35) or VILEVEV MB Urinary Antispetic (90 Tablets per Bottle, NDC 71186-000-24).

Inspect the label for the following VILAMIT MB lot numbers and expiration dates: 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), or M824G19-1 (Exp 07/21).

Inspect the label for the following VILEVEV MB lot numbers and expiration dates: M823J18-1, M823J18-2, or M823J18-3 (all Exp 09/20), and M823D19-1 (Exp 04/21).

If your medication is part of this recall, contact your healthcare provider or pharmacist immediately to discuss alternative treatment and stop using the affected lot.

Return any unused product to the pharmacy or place of purchase for a full refund.

Contact Vilvet Pharmaceuticals Inc. at their distributor address (1208 Kimberton Rd Ste 101, Chester Springs, PA) for further instructions on returning the product.

For additional information, contact the FDA Consumer Complaint line at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Affected Products

Product: VILAMIT MB (100 Capsules per Bottle)

Model:

NDC 71186-002-35

Lot Numbers:

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)

M824G19-1 (Exp 07/21)

Date Ranges: August 2020, September 2020, November 2020, January 2021, March 2021, July 2021

Product: VILEVEV MB Urinary Antispetic (90 Tablets per Bottle)

Model:

NDC 71186-000-24

Lot Numbers:

M823J18-1 (Exp 09/20)

M823J18-2 (Exp 09/20)

M823J18-3 (Exp 09/20)

M823D19-1 (Exp 04/21)

Date Ranges: September 2020, April 2021