Why it was recalled
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
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
Lot numbers, UPCs & expiration codes
Lot #: RX1662, RX1663, RX1664 Exp. 11/2022
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0324-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 31, 2021
- FDA report date
- Apr 14, 2021
- Quantity
- 55620 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0324-2021, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 87648
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lot #: RX1662, RX1663, RX1664 Exp. 11/2022
- Postal code
- 33326-3253
- Report date
- Apr 14, 2021
- Product type
- Drugs
- Recall number
- D-0324-2021
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 55620 bottles
- Reason for recall
- Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 31, 2021
- Initial firm notification
- Press Release
- Center classification date
- Apr 6, 2021