D-0324-2021 Class II Ongoing
FDA drug recall D-0324-2021 was initiated by Apotex Corp. on Mar 31, 2021 and is designated Class II. Reason for recall: Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate The recall status is ongoing. Affected quantity: 55620 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 14, 2021
- Initiation Date
- Mar 31, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55620 bottles
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
Distribution pattern
Nationwide within the United States
Code information
Lot #: RX1662, RX1663, RX1664 Exp. 11/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0324-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026