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Alprazolam FDA Alerts

The FDA Alerts below may be specifically about alprazolam or relate to a group or class of drugs which include alprazolam.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for alprazolam

Drug Safety Communication: Benzodiazepine Drug Class - Boxed Warning Updated to Improve Safe Use

ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.

Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.

BACKGROUND: Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder.

RECOMMENDATION:

Health Care Professionals

Patients, Parents, and Caregivers

  • Always tell your health care professionals about all the prescription and over-the-counter (OTC) medicines you are taking or any other substances you are using, including alcohol.
  • Take benzodiazepines and all medicines exactly as prescribed by your health care professional
  • Discuss a plan for slowly decreasing the dose and frequency of your benzodiazepine(s) with your health care professional.
  • Contact your health care professional if you experience withdrawal symptoms or your medical condition worsens.
  • Go to an emergency room or call 911 if you have trouble breathing or other serious side effects such as seizures.

Patients and health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Source: FDA


Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance

October 26, 2019 -- Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of foreign substance. Clinical impact from the foreign material, if present, is expected to be rare, but the remote risk of infection to a patient cannot be ruled out. To date, Mylan has not received any adverse events related to this batch.

Alprazolam Tablets are indicated for the management of anxiety disorder, the short-term relief of symptoms of anxiety, and the treatment of panic disorder, with or without agoraphobia.

Alprazolam Tablets, USP C-IV 0.5 mg, are packaged in bottles of 500. This batch was distributed in the U.S. between July 2019 and August 2019. The recalled lot is as follows:

NDC

Product Description and Strength

Size

Lot number

Expiry

0378-4003-05 Alprazolam Tablets, USP C-IV 0.5 mg Bottles of 500 8082708 September 2020

Mylan has notified its distributors and customers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:

  • Wholesaler: Immediately examine your inventory, quarantine and discontinue distribution of these lots. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to mylan5924@stericycle.com within 10 business days. Stericycle will notify your retail level customers that received the affected batches.
  • Retailer: Immediately examine your inventory, quarantine and discontinue distribution of these lots. Additionally, if you have further distributed the product, please identify the consumer and notify them immediately of this product recall. The consumer should be instructed to contact Stericycle at 1-888-843-0255 for the documentation packet to return the product.
  • Consumer: Please contact Stericycle at 1-888-843-0255 for the documentation packet to return product to Stericycle.

Consumers with questions regarding this recall can contact Mylan Customer Relations at 800.796.9526 or customer.service@mylan.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration

Source: FDA


Xanax (alprazolam)

[Posted 02/16/2007] FDA informed consumers and healthcare professionals regarding the possible dangers of buying prescription medications online. Individuals who ordered Ambien, Xanax, Lexapro, and Ativan over the internet received a product that contained haloperidol, a powerful anti-psychotic drug. Several consumers experienced difficulty in breathing, muscle spasms and muscle stiffness after ingesting the suspect product and had to seek emergency medical treatment. Haloperiodol can cause muscle stiffness, spasms, agitation and sedation. Taking medication that contains an active ingredient other than what is prescribed by qualified healthcare professionals is generally unsafe. FDA urges consumers to review the FDA website for additional information prior to making purchases of medications over the internet (http://www.fda.gov/ForConsumers/ProtectYourself/default.htm).

[February 16, 2007 - News Release - FDA]

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