April 15, 2021
Apotex Corp is voluntarily recalling 55,620 bottles of guanfacine extended-release tablets, 2 mg, because trace amounts of the schizophrenia drug quetiapine fumarate were found in products from one of the lots. The recall was included in the April 14, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects guanfacine extended-release tablets, 2 mg, 100-count bottles, from lots RX1662, RX1663, and RX1664 (Exp. 11/22). The tablets were manufactured by Apotex Inc., Toronto, Ontario, Canada, for Apotex Corp., Weston, Florida, and distributed throughout the United States between December 22, 2020, and March 19, 2021.
According to a March 31, 2021, company statement announcing the recall, trace amounts of quetiapine fumarate were found in lot RX1663. However, Apotex Corp. opted to include lots RX1662 and RX1664 in the recall because they were manufactured in the same campaign as lot RX1663.
The FDA designated the recall Class II on April 6, 2021. Drugs affected by Class II recalls could cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
“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,” Apotex Corp. explained in the statement. “Pediatric patients, pregnant patients, and older adults may be more likely to experience low blood pressure and dizziness if exposed to the defective product.”
As of March 31, 2021, the company had not received any reports of adverse events related to the recall.
Guanfacine is a prescription drug used to treat attention-deficit/hyperactivity disorder. Quetiapine is a prescription medication indicated for the treatment of schizophrenia and other serious mental disorders such as bipolar disorder and depressive episodes.