WASHINGTON, DC – According to a recall notice published by the U.S. Food and Drug Administration, Apotex Corp. has issued a nationwide recall of its Guanfacine Extended-Release Tablets 2mg due to “trace amounts” of prescription drug Quetiapine Fumarate. Apotex Corp., based in Weston, Florida, is recalling three lots of its “Guanfacine Extended-Release Tablets 2mg” sold at the consumer level because of the detection of Quetiapine Fumarate. The recalled lot numbers include RX1663, RX1662, and RX1664.
Guanfacine is a stimulant that is meant to treat Attention Deficit Hyperactivity Disorder (ADHD). Quetiapine is also used for the treatment of serious mental disorders such as Schizophrenia, Bipolar Disorder manic episodes, Bipolar Disorder, and other depressive episodes. Customers who unknowingly consume Quetiapine Fumarate can experience a hypersensitivity reaction such as an unsafe lowering of blood pressure, sleepiness, sedation, and dizziness. Pregnant patients, pediatric patients, and older adults are more likely to experience dangerous side effects such as low blood pressure and dizziness if exposed to the product. Apotex Corp has not received any adverse event reports related to this recall.
The recalled Guanfacine Extended-Release Tablets are identifiable by the NDC numbers listed on the product’s label. The lot numbers and expiration dates can be found on the product’s left side of the product description next to the barcode. The recalled lots were sold in the United States between December 22, 2020, to March 19, 2021.
|Product:||Pack Size:||Strength:||NDC Number:||UPC Codes:||Lot Numbers:||Expiry Date:|
|Guanfacine Extended-Release Tablets||100 Tablets||2 mg||60505-3928-1||3 60505 39281 0||RX1662, RX1663, RX1664||11/2022|
According to Apotex Corp, the three (3) lots of recalled Guanfacine extended-release tablets were distributed nationwide to wholesalers, warehousing chains, distributors, independent retail pharmacies, and retail buying groups. Apotex Corp is currently arranging for the return of all recalled products.
Patients who have purchased any of the three impacted lots of Guanfacine Extended-Release Tablets or have any questions about this recall are urged to contact their pharmacy. Patients who have the recalled medication should immediately contact their doctor for medical advice and return the recalled product by contacting the company. The contact information and recall information can be found on the company’s website Apotex.com.
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