FDAClass IINovember 22, 2017

Urin D/S Tablets Methenamine 81.6 mg recall: Subpotent

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…

Why was Urin D/S Tablets Methenamine 81.6 mg 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Llorens Pharmaceutical Corp.
Quantity
19232 bottles
Distribution
Puerto Rico
Recall date
November 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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