The Recall Desk

FDA (Drugs) recall action 86069

Vilvet Pharmaceuticals Inc. recalled 2 products on 2020-08-12

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-08-12
Critical
0
Units
13,356

Why these products were recalled

cGMP deviations

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2020-08-12

    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.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2020-08-12

    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.

    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.
    Category
    Distribution
    0 states