Recalls / Class II
Class IID-0324-2021
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
- Brand name
- Guanfacine Extended-release
- Generic name
- Guanfacine
- Active ingredient
- Guanfacine Hydrochloride
- Route
- Oral
- NDCs
- 60505-3927, 60505-3928, 60505-3929, 60505-3930
- FDA application
- ANDA205430
- Affected lot / code info
- Lot #: RX1662, RX1663, RX1664 Exp. 11/2022
Why it was recalled
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, N/A, Weston, Florida 33326-3253
Distribution
- Quantity
- 55620 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-03-31
- FDA classified
- 2021-04-06
- Posted by FDA
- 2021-04-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0324-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.