Drug 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
D-0081-2018
Product summary
- Event
- Event 78074
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19232 bottles
- Official record key
drug-enforcement:D-0081-2018
Official wording
Reason: 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.
Code information: Lots: 22811601, 22811602, Exp. 05/18; 202U1601 Exp. 11/18
Distribution pattern: Puerto Rico
Derived failure modes
-
Potency or specification failure
Superpotent