FDA Drug recall D-1487-2020
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…
- FDA Drug
- Class II
- terminated
- Published 2020-08-12
On 2020-08-12 the FDA classified a Class II recall of 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… by Vilvet Pharmaceuticals, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1487-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-24 |
| Published | 2020-08-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vilvet Pharmaceuticals |
| Distribution | US |
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.
Reason
cGMP deviations
Identifiers
| code_info | LOT M824H18-1 EXP 08/20 LOT M824J18-1 EXP 09/20 LOT M824L18-1 EXP 11/20 LOT M824A19-1 EXP 01/21 LOT M824C19-1 EXP 03/21 LOT M824G19-1 EXP 07/21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1487-2020%22
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