FDA Drug Class II — Moderate

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

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.

Products

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 P
Brand
Llorens Pharmaceutical Corp.
UPC
Lots: 22811601, 22811602, Exp. 05/18; 202U1601 Exp. 11/18

Units Affected

19232 bottles