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| The United States: Mylan Pharmaceuticals initiates voluntary nationwide recall of one lot of Alprazolam Tablets, USP C-IV 0.5mg, due to the potential of foreign substance (English only) |
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The US Food and Drug Administration (FDA) announces that Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot of Alprazolam Tablets, USP C-IV 0.5mg (lot number: 8082708), 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, USP C-IV 0.5mg, are packaged in bottles of 500. This batch was distributed in the United States between July 2019 and August 2019.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-initiates-voluntary-nationwide-recall-one-lot-alprazolam-tablets-usp-c-iv-05
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Monday, Oct 28, 2019
Issued at HKT 16:00
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