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| The United States: Apotex Corp. issues voluntary nationwide recall of Guanfacine Extended-Release Tablets 2mg due to trace amounts of quetiapine fumarate (English only) |
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The US Food and Drug Administration (FDA) announces that Apotex Corp is voluntarily recalling three lots of Guanfacine Extended-Release Tablets 2mg (lot number: RX1662, RX1663 and RX1664) to the consumer level due to trace amounts of quetiapine fumarate in one lot RX1663. Out of an abundance of caution, lots RX1662 and RX1664 are also included in the scope of this voluntary recall, as they were manufactured in the same campaign as lot RX1663.
Administration of Guanfacine Extended-Release Tablets containing trace amounts of quetiapine fumarate to a patient can result in the possibility of hypersensitivity reaction and may potentially have additive effects in lowering blood pressure, sleepiness/sedation, and dizziness. Pediatric patients, pregnant patients and older adults may be more likely to experience low blood pressure and dizziness if exposed to the defective product. To date, Apotex Corp has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-guanfacine-extended-release-tablets-2mg-due-trace
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Apr 1, 2021
Issued at HKT 16:00
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