Drug Safety Alerts

Guanfacine Extended-Release 2 mg Tablets Consumer-Level Recall

3/31/2021

On March 31, 2021, Apotex Corp issued a consumer-level recall of Guanfacine Extended-Release 2mg tablets NDC # 60505-3928-01. This recall was issued 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.

This may represent a potential health hazard or safety risk to patients using product affected by this recall.

According to Apotex, a Health Hazard Assessment concluded 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. Apotex Corp has advised that to date it has not received any reports of adverse events related to this recall.

Apotex Corp recommends that patients should not interrupt their therapy, contact their health care provider for medical advice and should return product to their pharmacy.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Guanfacine Extended-Release 2mg tablets to contact their prescriber.

For more information about this recall, please contact Apotex Corp at 1-800-706-5575 or visit www1.apotex.com.

You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.