Why it was recalled
Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
Product description
Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, Rx Only, 100-count bottle, Manufactured For: Llorens Pharmaceutical Corp., International Division, Miami, FL 33166. NDC: 54859-701-10
Lot numbers, UPCs & expiration codes
Lots: 22811601, 22811602, Exp. 05/18; 202U1601 Exp. 11/18
Where it was sold
Puerto Rico
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-0081-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 5, 2017
- FDA report date
- Nov 22, 2017
- Quantity
- 19232 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Llorens Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-0081-2018, exactly as published.
Show all FDA fields
- City
- Caguas
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 78074
- Address
- Carr. #1 Km 34.3
- Code information
- Lots: 22811601, 22811602, Exp. 05/18; 202U1601 Exp. 11/18
- Postal code
- 00725
- Report date
- Nov 22, 2017
- Product type
- Drugs
- Recall number
- D-0081-2018
- Classification
- Class II
- Recalling firm
- Llorens Pharmaceutical Corp.
- Product quantity
- 19232 bottles
- Termination date
- Apr 3, 2019
- Reason for recall
- Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, Rx Only, 100-count bottle, Manufactured For: Llorens Pharmaceutical Corp., International Division, Miami, FL 33166. NDC: 54859-701-10
- Distribution pattern
- Puerto Rico
- Recall initiation date
- Sep 5, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 15, 2017