The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0550-2023·Announced 2023-05-03

Prescription drug recall for manufacturing quality control deviations

Northwind Pharmaceuticals is recalling 33 bottles of Doxazosin 4mg tablets due to manufacturing quality control deviations. No illnesses or injuries have been reported.

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 with CGMP deviations represents a risk of harm with no reported illnesses or injuries, fitting the Score 3 (High) criterion for risk-of-harm products without reported injury.

Plain-English summary

Northwind Pharmaceuticals LLC is recalling 33 bottles of Doxazosin Tablets, USP 4mg (prescription only) because of Current Good Manufacturing Practice (CGMP) deviations. The affected product has lot number F107752201 and an expiration date of May 31, 2024. The product was distributed nationwide across the United States.

CGMP deviations indicate quality control and manufacturing practice concerns that could affect the safety and efficacy of the medication. Northwind Pharmaceuticals initiated this voluntary recall on March 16, 2023.

No illnesses or injuries have been reported in connection with this recall. Consumers who have received this medication should consult with their healthcare provider or pharmacist. Healthcare providers and pharmacists should identify and quarantine affected product and return it to the distributor.

The recalled product

Product
DOXAZOSIN (DOXAZOSIN)
Brand
DOXAZOSIN
Manufacturer
Northwind Pharmaceuticals LLC
Category
Drug — Prescription
Hazard
Affected units
33

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 (2)

  • Lot#: F107752201
  • Exp. Date 05/31/2024

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Northwind Pharmaceuticals LLC 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 7 products in this recall →

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