Llorens Pharmaceutical Recalls Urin D/S Tablets Due to Potency Issues
Llorens Pharmaceutical Corp. is recalling Urin D/S Tablets because FDA analysis found the product to be out of specification for assay, resulting in subpotent or superpotent tablets.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the defect involves significant potency deviations that could impact therapeutic efficacy or safety.
Plain-English summary
Llorens Pharmaceutical Corp. is recalling Urin D/S Tablets (NDC: 54859-701-10) in 100-count bottles. The affected lots are 22811601, 22811602 (Exp. 05/18), and 202U1601 (Exp. 11/18). A total of 19,232 bottles were distributed in Puerto Rico.
The recall was initiated because FDA analysis determined the product was out of specification for assay. This defect could result in tablets that are either subpotent (containing less active ingredient than labeled) or superpotent (containing more active ingredient than labeled).
Consumers who have these specific lots of Urin D/S Tablets should stop using them and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- 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
- Manufacturer
- Llorens Pharmaceutical Corp.
- Category
- Drug — Prescription Medication
- Affected units
- 19,232
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots: 22811601
- 22811602
- Exp. 05/18
- 202U1601 Exp. 11/18
Distribution
Distributed in 1 state:
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