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Xanax Recalled due to the Presence of a Foreign Substance


November 02, 2019

UNITED STATES – According to an online news report at miamiherald.com, Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (identified below) of Alprazolam (Xanax) tablets, USP C-IV 0.5 mg, to the consumer/user level.

This lot of Xanax is the subject of a recall due to the potential presence of a foreign substance in the medication.  The impact associated with consuming the foreign substance, if presence, is low however, there is a remote risk of infection that cannot be ruled out.  Thus far, Mylan has not received any complaints of adverse events associated with the affected batch of Xanax.

Xanax is indicated for the treatment of anxiety and panic disorder, with or without agoraphobia. Xanax, USP C-IV 0.5 mg, are packed in bottles of 500.  The affected batch was distributed in the United States between July and August of 2019. The recalled lot is:

NDC

Product Description and Strength

Size

Lot number

Expiration

0378-4003-05

Alprazolam Tablets, USP C-IV 0.5 mg

Bottles of 500

8082708

September 2020

Mylan has already notified its distributors and customers by letter and is arranging for the return of all of its recalled products.  

Consumers with questions regarding this recall can contact Mylan Customer Relations at 800.796.9526 or [email protected], 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.

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Source:https://www.miamiherald.com/news/health-care/article236710813.html and https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-initiates-voluntary-nationwide-recall-one-lot-alprazolam-tablets-usp-c-iv-05

Category: Product Liability

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