Accord Healthcare Doxazosin Tablets Recalled for Manufacturing Deviations
Accord Healthcare recalls 31,116 bottles of Doxazosin Tablets USP 8 mg due to manufacturing practice deviations identified during FDA inspection. Distribution covered the US, Puerto Rico, and Canada.
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: FDA Class II recall with no reported illnesses, injuries, or deaths. The recall addresses manufacturing process deviations discovered during FDA inspection, making this a precautionary action.
Plain-English summary
Accord Healthcare, Inc. is recalling Doxazosin Tablets USP, 8 mg (Rx Only), a prescription medication. The recall affects approximately 31,116 bottles distributed in the United States, including Puerto Rico and Canada.
The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations. The product is manufactured by Intas Pharmaceuticals Limited in India and distributed by Accord Healthcare, Inc., Durham, NC.
Affected batches include: R2200672 (expires 5/31/2024), R2200673 (expires 9/30/2024), R2201097 (expires 7/31/2025), and R2200678 (expires 10/31/2024). Patients with affected medication should contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- DOXAZOSIN (DOXAZOSIN)
- Brand
- DOXAZOSIN
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug
- Hazard
- manufacturing-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 (8)
- Batches: a) R2200672
- Exp. Date 5/31/2024
- R2200673
- Exp. Date 9/30/2024
- R2201097
- Exp. Date 7/31/2025
- b) R2200678
- Exp. Date 10/31/2024
UPCs (2)
- 316729415019
- 316729415170
Distribution
Distribution scope not specified by the agency.
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