UTI Medication Recalled Due to Quality Defects
AvKARE, Inc., headquartered in Pulaski, Tennessee, has voluntarily initiated a recall of Nitrofurantoin capsules, USP, 100 mg due to failed dissolution specifications. This issue, identified in Lot #47101 (expiration date: February 2026), impacts a total of 1016 50-count cartons of the product distributed nationwide within the United States.
The recall, classified as Class II, was initiated on December 4, 2024, with notification provided via direct communication to consignees. A Class II recall indicates that use of the product may cause temporary or medically reversible adverse health consequences, but the probability of serious harm is low. Failed dissolution specifications suggest the drug may not release its active ingredient as intended, potentially compromising its effectiveness.
Nitrofurantoin is a prescription medication commonly prescribed for the treatment of urinary tract infections (UTIs) caused by susceptible bacterial strains.
