# FDA recall D-0081-2018

> **Llorens Pharmaceutical Corp.** · Class II · drug recall initiated 2017-09-05.

## 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 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

## Key facts

- **Recall number:** D-0081-2018
- **Recalling firm:** Llorens Pharmaceutical Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-05
- **Report date:** 2017-11-22
- **Termination date:** 2019-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Caguas, PR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0081-2018

## Citation

> AI Analytics. FDA recall D-0081-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0081-2018. Source: US FDA. Licensed CC0.

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