FDAFDA · Food and drugs·Recall number D-0081-2018
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
Published November 22, 2017 · Recall initiated: September 5, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Llorens Pharmaceutical Corp.
- Distributor
- Puerto Rico
- Lot
- Lots: 22811601, 22811602, Exp. 05/18; 202U1601 Exp. 11/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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