The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0389-2023·Announced 2023-03-08

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units
31,116

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

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 67 products in this recall →

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