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.,

FDA recall notice · announced August 12, 2020 · Vilvet Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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, NDC 71186-000-24.

Reason for recall

cGMP deviations

Notes

Distribution: Nationwide within the US
Lot/code information: LOT M823J18-1, M823J18-2, M823J18-3 EXP 09/20; LOT M823D19-1 EXP 04/21
Quantity: 1,716 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1487-2020)
- 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 B (D-1488-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.