PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: August 12, 2020 Initiated: July 24, 2020 #D-1487-2020

Product Description

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.

Reason for Recall

cGMP deviations

Details

Units Affected
11,640 bottles
Distribution
Nationwide within the US
Location
Chester Springs, PA

Frequently Asked Questions

What product 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.. Recalled by Vilvet Pharmaceuticals Inc.. Units affected: 11,640 bottles.
Why was this product recalled?
cGMP deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on August 12, 2020. Severity: Moderate. Recall number: D-1487-2020.