Class II
Terminated
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
- Company
- Llorens Pharmaceutical Corp.
- Recall Initiated
- September 5, 2017
- Posted
- November 22, 2017
- Recall Number
- D-0081-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 19232 bottles
- Firm Location
- Caguas, PR, United States
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
Lot / Code Info
Lots: 22811601, 22811602, Exp. 05/18; 202U1601 Exp. 11/18
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