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FDASeptember 5, 2017drug

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

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

llorens pharmaceuticalllorens

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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