Apotex Recalls Guanfacine Extended-Release Tablets Due to Cross-Contamination
Apotex Corp. is recalling Guanfacine Extended-Release tablets because they contain trace amounts of Quetiapine Fumarate.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard involves trace contamination with another drug, which is a moderate risk compared to high-risk pathogens or structural defects.
Plain-English summary
Apotex Corp. is recalling 55,620 bottles of Guanfacine Extended-Release Tablets 2 mg. The product is being recalled due to cross-contamination with trace amounts of Quetiapine Fumarate.
The affected product is identified by NDC 60505-3928-1 and includes lot numbers RX1662, RX1663, and RX1664, all with an expiration date of 11/2022. The bottles contain 100 tablets each and are marked as Rx Only.
The product was distributed nationwide within the United States. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- GUANFACINE EXTENDED-RELEASE (GUANFACINE)
- Brand
- GUANFACINE EXTENDED-RELEASE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Prescription Drug
- Affected units
- 55,620
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: RX1662
- RX1663
- RX1664 Exp. 11/2022
UPCs (1)
- 360505392810
Distribution
Distributed nationwide across the United States.
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