FDA recall D-0081-2018

Product

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

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.

Distribution

Puerto Rico

Key facts

Status

Terminated

Initiation date

2017-09-05

Report date

2017-11-22

Termination date

2019-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Caguas, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0081-2018