September 2017 FDA Recall Drug by Llorens Pharmaceutical Corp.
D-0081-2018 - Superpotent Drug

This Class II drug recall was voluntarily initiated by Llorens Pharmaceutical Corp. on September 5, 2017 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed in Puerto Rico and the recall is currently terminated.

Recall Number: D-0081-2018

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.
Initiated
09-05-2017
Reported
11-22-2017
Quantity
19232 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78074
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Llorens Pharmaceutical Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-03-2019
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lots: 22811601, 22811602, Exp. 05/18; 202U1601 Exp. 11/18