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
Audience: Consumer, Health Professional, Pharmacy
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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration
Source: FDA
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