D-0081-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 22, 2017
- Initiation Date
- September 5, 2017
- Termination Date
- April 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19232 bottles
Product Description
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 Pattern
Puerto Rico
Code Information
Lots: 22811601, 22811602, Exp. 05/18; 202U1601 Exp. 11/18