FDA Recall D-0324-2021

Apotex Corp. · Weston, FL

Class II Ongoing 1870 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lot #: RX1662, RX1663, RX1664 Exp. 11/2022

Quantity: 55620 bottles

Reason for recall

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

Recall record

Recall number: D-0324-2021
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide within the United States
Recall initiated: 2021-03-31
Classified by FDA Center: 2021-04-06
FDA published: 2021-04-14
Recalling firm: Apotex Corp.
Firm location: Weston, FL

Drug identification

Brand name(s): GUANFACINE EXTENDED-RELEASE
Generic name(s): GUANFACINE
Manufacturer(s): Apotex Corp.
NDC(s): 60505-3927, 60505-3928, 60505-3929, 60505-3930
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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