Drug 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
D-0324-2021
Product summary
- Firm
- Apotex Corp.
- Event
- Event 87648
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 55620 bottles
- Official record key
drug-enforcement:D-0324-2021
Official wording
Reason: Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Code information: Lot #: RX1662, RX1663, RX1664 Exp. 11/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate