The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0492-2023·Announced 2023-04-12

Doxazosin 2 mg tablets recalled for manufacturing practice deviations

RemedyRepack Inc. is voluntarily recalling Doxazosin 2 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 30-count and 90-count bottles.

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 3/5 (High).

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: FDA Class II classification with cGMP deviations affecting a prescription medication and no reported illnesses or injuries. This qualifies as a risk-of-harm product per the rubric's Score 3 criterion.

Plain-English summary

RemedyRepack Inc. is recalling Doxazosin 2 mg tablets due to current Good Manufacturing Practice (cGMP) deviations. The affected products are packaged in 30-count (NDC 70518-1560-00) and 90-count (NDC 70518-1560-01) bottles and were distributed nationwide to consignees within the United States.

The affected lot numbers include J0665197-120522 (expiration 12/31/2023), J0642497-082722 (expiration 09/30/2023), J0638552-080922 (expiration 08/31/2023), and B1808799-081622 (expiration 05/31/2024). In total, 58 bottles of the 30-count packaging and 6 bottles of the 90-count packaging were included in this recall.

This is a voluntary recall initiated by the firm.

The recalled product

Product
Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Manufacturer
RemedyRepack Inc.
Category
Drug
Hazard

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 (6)

  • Lot #: a) J0665197-120522
  • Exp. Date 12/31/2023
  • J0642497-082722
  • Exp. Date 09/30/2023 J0638552-080922
  • Exp. Date 08/31/2023. Lot #: b) B1808799-081622
  • Exp. Date 05/31/2024

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by RemedyRepack 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 14 products in this recall →

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