Medications & Supplements/Prescription Drugs

Llorens Pharmaceutical Corp.: Urin D/S Tablets Recalled Due to Potency Testing Failures

Agency Publication Date: November 15, 2017

Summary

Llorens Pharmaceutical Corp. is recalling 19,232 bottles of Urin D/S (methenamine, sodium biphosphate, phenyl salicylate, methylene blue, and hyoscyamine sulfate) tablets. FDA testing discovered that the tablets are "out of specification," meaning they could be either subpotent (not enough medication) or superpotent (too much medication). Consumers should be aware that these prescription tablets are sold in 100-count bottles and were distributed in Puerto Rico. If you have this medication, you should contact your doctor or pharmacist to discuss your treatment and return the product to where you purchased it.

Risk

Subpotent tablets may fail to treat the underlying condition effectively, while superpotent tablets could lead to an accidental overdose of the active ingredients, including hyoscyamine sulfate and methylene blue, potentially causing serious adverse health effects.

What You Should Do

Check your Urin D/S Tablets 100-count bottles for the following lot numbers and expiration dates: Lot 22811601 (Exp. 05/18), Lot 22811602 (Exp. 05/18), or Lot 202U1601 (Exp. 11/18).
Locate the NDC (National Drug Code) 54859-701-10 on the bottle label to confirm your product is part of the recall.
If your medication matches the affected lots, contact your healthcare provider or pharmacist immediately to obtain a replacement prescription and ensure your treatment is not interrupted.
Return any unused tablets and the bottle to the pharmacy or place of purchase for a refund.
Contact Llorens Pharmaceutical Corp. at their Caguas, Puerto Rico facility for further instructions regarding the return process.
For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall baseline remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

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 (100-count bottle)

Model:

NDC: 54859-701-10

Lot Numbers:

22811601 (Exp. 05/18)

22811602 (Exp. 05/18)

202U1601 (Exp. 11/18)

Date Ranges: Expiration 05/18, Expiration 11/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78074

Status: Resolved

Manufacturer: Llorens Pharmaceutical Corp.

Sold By: Pharmacies in Puerto Rico

Manufactured In: United States

Units Affected: 19232 bottles

Distributed To: Puerto Rico

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your Urin D/S Tablets 100-count bottles for the following lot numbers and expiration dates: Lot 22811601 (Exp. 05/18), Lot 22811602 (Exp. 05/18), or Lot 202U1601 (Exp. 11/18).

Locate the NDC (National Drug Code) 54859-701-10 on the bottle label to confirm your product is part of the recall.

If your medication matches the affected lots, contact your healthcare provider or pharmacist immediately to obtain a replacement prescription and ensure your treatment is not interrupted.

Return any unused tablets and the bottle to the pharmacy or place of purchase for a refund.

Contact Llorens Pharmaceutical Corp. at their Caguas, Puerto Rico facility for further instructions regarding the return process.

For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.