Doxazosin tablets recalled due to manufacturing quality control deviations
Accord Healthcare is recalling 75,190 bottles of Doxazosin 4 mg tablets due to manufacturing quality control deviations discovered during an FDA inspection. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The manufacturing quality control deviations identified during FDA inspection represent a potential risk of harm where injury has not yet been reported.
Plain-English summary
Accord Healthcare, Inc. is recalling Doxazosin tablets USP, 4 mg, due to manufacturing quality control deviations identified during a U.S. Food and Drug Administration inspection.
The recall affects 75,190 bottles distributed in the United States, including Puerto Rico and Canada. Affected batches are: R2200352 (expires 5/31/2024), R2200356 (expires 8/31/2024), R2200357 (expires 8/31/2024), R2200633 (expires 4/30/2025), R2200634 (expires 4/30/2025), R2200677 (expires 8/31/2024), R2200572 (expires 4/30/2025), R2200571 (expires 4/30/2025), and R2200646 (expires 4/30/2025). The affected product is sold under NDC numbers 16729-213-01 (100-count bottles) and 16729-213-17 (1,000-count bottles).
Patients currently taking this medication should not stop their medication without consulting their healthcare provider or pharmacist. No illnesses or adverse events associated with this recall have been reported.
The recalled product
- Product
- DOXAZOSIN (DOXAZOSIN)
- Brand
- DOXAZOSIN
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug
- Hazard
- cgmp-deviation
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 (12)
- Batches: a) R2200352
- Exp. Date 5/31/2024
- R2200356
- Exp. Date 8/31/2024
- R2200357
- R2200633
- Exp. Date 4/30/2025
- R2200634
- b) R2200677
- R2200572
- R2200571
- R2200646
UPCs (2)
- 316729213011
- 316729213172
Distribution
Distribution scope not specified by the agency.
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