on PinterestThe FDA issued a nationwide recall of Xanax XR for failing to meet dissolution specifications.
on PinterestThe FDA issued a nationwide recall of Xanax XR for failing to meet dissolution specifications. BSIP/Universal Images Group via Getty Images
- The FDA has issued a report regarding the voluntary recall of a single lot of Xanax XR.
- Viatris has recalled 3-milligram tablets in 60-tablet bottles with the lot number 8177156.
- The company reports that this lot failed to meet dissolution specifications.
- Experts say this could cause the pills to not be as effective in controlling symptoms.
- They advise that you continue taking the pills until your doctor can issue a new prescription.
A nationwide recall of Xanax has many people wondering whether their anti-anxiety medication has been affected.
According to an Enforcement Report issued by the Food and Drug Administration (FDA), Viatris, Inc., a major pharmaceutical company, has voluntarily recalled a specific lot of Xanax XR (alprazolam extended-release tablets) distributed across the United States.
The recall, initiated on March 17, affects 3-milligram tablets packaged in 60-tablet bottles, produced in Ireland and distributed by Viatris Specialty LLC in Morgantown, W.Va.
The decision comes after the product failed to meet dissolution specifications, which are critical for ensuring proper drug release and effectiveness.
Patients and healthcare providers are urged to check their medication and contact Viatris or their healthcare professional if they have the affected lot, numbered 8177156, with an expiration date of February 28, 2027.
No safety concerns over affected Xanax XR pills
The issue was identified through quality control testing, which revealed that the tablets failed to meet the FDA dissolution specifications.
Dissolution testing measures how quickly and efficiently the active ingredient is released from the tablet into the body.
As noted in the Enforcement Report, the formulation of the drug being recalled is Xanax XR, a medication commonly prescribed for the treatment of anxiety and panic disorders.
This extended-release formulation is designed to release the medication gradually over time, providing more consistent symptom control.
Aleksey Aronov, AGPCNP-BC, a board certified adult geriatric primary care nurse practitioner and the founder and CEO of VIPs IV, told Healthline that if the pill does not meet dissolution specifications, it may not break down as it should in the body, which could result in the medicine not working properly.
“When a pill does not dissolve the right way, the body may not absorb the correct amount of the medicine, which may result in not treating anxiety or panic symptoms appropriately,” he said. “Pills that fail to dissolve essentially may not be effective.”
The Enforcement Report further notes that the recall is classified by the FDA as a Class II recall. Class II indicates that the use of this medication could cause “temporary or medically reversible adverse health consequences,” however, there is little risk of serious adverse health consequences, according to the agency.
Aronov clarified this description further by explaining that failed dissolution is not a safety hazard, nor will the drug cause harm to your body.
“It is just a quality control issue that may result in the patient not benefiting from the medicine when they take it,” he said.
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