CLASS II Drug recall · Reported 22 Nov 2017 · FDA Enforcement Report
Urin D/S Tablets Methenamine 6 mg, Sodium Biphosphate 8 mg recalled
Llorens Pharmaceutical is recalling Urin D/S Tablets Methenamine 6 mg, Sodium Biphosphate 8 mg, Phenyl Salicylate 2 mg, distributed in Puerto Rico. The recall was initiated on 5 Sep 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0081-2018
- FDA event ID
- 78074
- Recalling firm
- Llorens Pharmaceutical, Caguas, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Sep 2017
- FDA classified
- 15 Nov 2017
- Reported
- 22 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 5 Sep 2017 | Recall initiated by company | |
| 15 Nov 2017 | Classified by FDA | +71 days |
| 22 Nov 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Puerto Rico
Questions about this recall
Is Urin D/S Tablets Methenamine 6 mg, Sodium Biphosphate 8 mg, Phenyl Salicylate 2 mg recalled?
Yes. Llorens Pharmaceutical recalled Urin D/S Tablets Methenamine 6 mg, Sodium Biphosphate 8 mg, Phenyl Salicylate 2 mg on 5 Sep 2017. The recall is Class II and its status is Terminated. Recall number D-0081-2018.
Why was it recalled?
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.
Which lots are affected?
Lots: 22811601, 22811602, Exp. 05/18; 202U1601 Exp. 11/18
Where was it sold?
Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.