Why it was recalled
cGMP deviations
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide within the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1487-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2020
- FDA report date
- Aug 12, 2020
- Quantity
- 11,640 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vilvet Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1487-2020, exactly as published.
Show all FDA fields
- City
- Chester Springs
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 86069
- Address
- 1208 Kimberton Rd Ste 101
- Code information
- 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
- Postal code
- 19425-1437
- Report date
- Aug 12, 2020
- Product type
- Drugs
- Recall number
- D-1487-2020
- Classification
- Class II
- Recalling firm
- Vilvet Pharmaceuticals Inc.
- Product quantity
- 11,640 bottles
- Termination date
- Jan 21, 2022
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within the US
- Recall initiation date
- Jul 24, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 6, 2020