US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Mar 31, 2021 (5 years ago)

Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate

What was recalled

Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0

Recalling firm
Apotex Corp.
NDC code
60505-3928-1
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0324-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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