FDA Drug recall D-0081-2018
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.…
- FDA Drug
- Class II
- terminated
- Published 2017-11-22
On 2017-11-22 the FDA classified a Class II recall of 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.… by Llorens Pharmaceutical, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0081-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-05 |
| Published | 2017-11-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Llorens Pharmaceutical |
| Distribution | PR |
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
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.
Identifiers
| code_info | Lots: 22811601, 22811602, Exp. 05/18; 202U1601 Exp. 11/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0081-2018%22
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