PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: April 14, 2021 Initiated: March 31, 2021 #D-0324-2021

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Apotex Corp.
Units Affected
55620 bottles
Distribution
Nationwide within the United States
Location
Weston, FL

Frequently Asked Questions

What product 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. Recalled by Apotex Corp.. Units affected: 55620 bottles.
Why was this product recalled?
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Which agency issued this recall?
This recall was issued by the FDA Drug on April 14, 2021. Severity: Moderate. Recall number: D-0324-2021.