March 2021 FDA Recall Guanfacine Extended-release by Apotex Corp.
D-0324-2021 - Cross Contamination with Other Product
This Class II drug recall was voluntarily initiated by Apotex Corp. on March 31, 2021 for the product Guanfacine Extended-release. The FDA reported the reason for recall as cross contamination with other product. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0324-2021
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
03-31-2021
04-14-2021
55620 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Apotex Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : RX1662, RX1663, RX1664 Exp. 11/2022
