FDA Drug recall D-0324-2021
Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc
- FDA Drug
- Class II
- ongoing
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc by Apotex, citing cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0324-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-31 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apotex |
| Distribution | US |
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
Reason
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Identifiers
| upc | 360505392810 |
|---|---|
| ndc | 60505-3927-3 |
| ndc | 60505-3927-1 |
| ndc | 60505-3927-8 |
| ndc | 60505-3928-3 |
| ndc | 60505-3928-1 |
| ndc | 60505-3928-8 |
| ndc | 60505-3929-3 |
| ndc | 60505-3929-1 |
| ndc | 60505-3929-8 |
| ndc | 60505-3930-3 |
| ndc | 60505-3930-1 |
| ndc | 60505-3930-8 |
| code_info | Lot #: RX1662, RX1663, RX1664 Exp. 11/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-04-22 · Apotex - Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp
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FDA Drug · Class II · 2025-10-08 · Apotex
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0324-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.