Reported Nov 22, 2017 · Terminated
Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg,…
Llorens Pharmaceutical Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Llorens Pharmaceutical Corp. · Carr. #1 Km 34.3 · Caguas, PR · 00725
Is this the product you have?
Urin D/S Tablets Methenamine 81.6 mgSodium Biphosphate 40.8 mgPhenyl Salicylate 36.2 mgMethylene Blue 10.8 mgHyoscyamine Sulfate 0.12 mgRx Only100-count bottle
- Manufactured ForLlorens Pharmaceutical Corp., International Division, Miami, FL 33166
- NDC54859-701-10
- Lot codes and dates
- Lots
2281160122811602Exp. 05/18202U1601 Exp. 11/18
- Lots
- Amount recalled
- 19232 bottles
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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