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

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

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-initiates-voluntary-nationwide-recall-one-lot-alprazolam-tablets-usp-c-iv-05

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Potential presence of foreign substance
Company Name:
Mylan Pharmaceuticals Inc.
Brand Name:
Mylan Pharmaceuticals Inc.
Product Description:
Alprazolam Tablets, USP C-IV 0.5 mg

Company Announcement

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


Company Contact Information

Consumers:
Stericycle
1-888-843-0255

One Response

  1. They won’t tell us which dirty, third world factory these were manufactured in. It was really innovative that the FDA got rid of inspectors, and stopped inspecting overseas manufacturing plants. Of course if any patients report problems with these contaminated drugs, they will be gas lighted by their physicians and the FDA will bury the data.

    Industry insiders and corrupt politicians decided that the FDA no longer needed to inspect these factories, after all inspections and quality control could cut into industry profits.

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