Alprazolam Tablets Recalled for Foreign Substance

Mylan Pharmaceuticals Inc. is operating a voluntary nationwide recall of one lot of Alprazolam Tablets, USP C-IV 0.5 mg to the consumer/user level. This recall stems from the potential presence of foreign substance, and to date, Mylan has not received any adverse events related to this batch.

Mylan Pharmaceuticals Inc. is operating a voluntary nationwide recall of one lot of Alprazolam Tablets, USP C-IV 0.5 mg to the consumer/user level. This recall stems from the potential presence of foreign substance, and to date, Mylan has not received any adverse events related to this batch.

Although the foreign material is expected to have a rare clinical impact, the remote risk of infection to a patient cannot be ruled out.

Alprazolam is 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.

The recalled lot is as follows:

  • NDC: 0378-4003-05
  • Product Description and Strength: Alprazolam Tablets, USP C-IV 0.5 mg
  • Size: Bottles of 500
  • Lot number: 8082708
  • Expiry: September 2020

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Any questions regarding this recall can be directed to Mylan Customer Relations at 800.796.9526 or customer.service@mylan.com, Monday through Friday from 8 a.m. — 5 p.m. EST.

Reference

Mylan Pharmaceuticals initiates voluntary nationwide recall of one lot of alprazolam tablets, USP C-IV 0.5 mg, due to potential of foreign substance [news release]. Morgantown, W.Va; Mylan Pharmaceuticals: October 25, 2019. https://investor.mylan.com/news-releases/news-release-details/mylan-pharmaceuticals-initiates-voluntary-nationwide-recall-one. Accessed October 26, 2019.