Medications & Supplements/Prescription Drugs

Northwind Pharmaceuticals Prescription Drugs Recalled for CGMP Deviations

Agency Publication Date: April 26, 2023

Summary

Northwind Pharmaceuticals LLC is recalling 753 bottles of various prescription medications, including Glimepiride, Atorvastatin Calcium, BusPIRone Hydrochloride, Doxazosin, and Tadalafil. These medications were repackaged by the firm and are being recalled due to manufacturing practice (CGMP) deviations that could affect the quality and safety of the drugs. The recall affects specific lot numbers and expiration dates for 30, 90, 15, and 6-count bottles.

Risk

The medications were produced under conditions that deviated from required manufacturing standards, which may impact their potency, safety, or effectiveness. Use of these medications could lead to suboptimal treatment or unintended health risks, though no specific injuries have been reported to date.

What You Should Do

This recall affects various prescription medications repackaged by Northwind Pharmaceuticals including Atorvastatin Calcium (10 mg), BusPIRone Hydrochloride (7.5 mg), Doxazosin (4 mg), Glimepiride (2 mg and 4 mg), and Tadalafil (5 mg and 20 mg).
Check the bottle label for the medication name, NDC number, lot number, and expiration date. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Northwind Pharmaceuticals LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Glimepiride Tablets, USP 4mg

Variants: 4mg, Tablet, 30-count bottle, 90-count bottle

Lot Numbers:

F105692201 (Exp. 09/30/2024)

F105692203 (Exp. 02/28/2025)

F105692202 (Exp. 02/28/2025)

NDC:

51655-120-52

51655-120-26

Recall #: D-0552-2023

Product: Atorvastatin Calcium Tablets, USP, 10 mg

Variants: 10 mg, Tablet, 30-count bottle

Lot Numbers:

F117192201 (Exp. 4/30/2023)

NDC:

51655-946-52

Recall #: D-0548-2023

Product: BusPIRone Hydrochloride Tablets USP, 7.5 mg

Variants: 7.5 mg, Tablet, 30-count bottle

Lot Numbers:

F117312201 (Exp. 06/30/2024)

NDC:

51655-511-52

Recall #: D-0549-2023

Product: Doxazosin Tablets, USP, 4mg

Variants: 4mg, Tablet, 30-count bottle

Lot Numbers:

F107752201 (Exp. 05/31/2024)

NDC:

51655-109-52

Recall #: D-0550-2023

Product: Glimepiride Tablets, USP 2mg

Variants: 2mg, Tablet, 30-count bottle, 90-count bottle

Lot Numbers:

F106252201 (Exp. 09/30/2024)

F106252301 (Exp. 5/31/2025)

F106252303 (Exp. 5/31/2025)

F106252304 (Exp. 07/31/2025)

F106252302 (Exp. 07/31/2025)

NDC:

51655-383-52

51655-383-26

Recall #: D-0551-2023

Product: Tadalafil Tablets, USP 20 mg

Variants: 20 mg, Tablet, 6-count bottle, 15-count bottle

Lot Numbers:

F113892002 (Exp. 08/31/2023)

F113892201 (Exp. 11/30/2023)

F113892001 (Exp. 08/31/2023)

F113892202 (Exp. 11/30/2023)

F113892203 (Exp. 12/31/2023)

NDC:

51655-473-87

51655-473-54

Recall #: D-0553-2023

Product: Tadalafil Tablets, USP 5 mg

Variants: 5 mg, Tablet, 30-count bottle

Lot Numbers:

F114302001 (Exp. 05/31/2023)

NDC:

51655-487-52

Recall #: D-0554-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91944

Status: Active

Manufacturer: Northwind Pharmaceuticals LLC

Sold By: Retail Pharmacies

Manufactured In: United States

Units Affected: 7 products (99 bottles; 6 bottles; 33 bottles; a) 230 bottles; b) 22 bottles; a) 198 bottles; b) 22 bottles; a)164 bottles; b) 198 bottles; 23 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects various prescription medications repackaged by Northwind Pharmaceuticals including Atorvastatin Calcium (10 mg), BusPIRone Hydrochloride (7.5 mg), Doxazosin (4 mg), Glimepiride (2 mg and 4 mg), and Tadalafil (5 mg and 20 mg).

Check the bottle label for the medication name, NDC number, lot number, and expiration date. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Northwind Pharmaceuticals LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Glimepiride Tablets, USP 4mg

Variants: 4mg, Tablet, 30-count bottle, 90-count bottle

Lot Numbers:

F105692201 (Exp. 09/30/2024)

F105692203 (Exp. 02/28/2025)

F105692202 (Exp. 02/28/2025)

NDC:

51655-120-52

51655-120-26

Recall #: D-0552-2023

Product: Atorvastatin Calcium Tablets, USP, 10 mg

Variants: 10 mg, Tablet, 30-count bottle

Lot Numbers:

F117192201 (Exp. 4/30/2023)

NDC:

51655-946-52

Recall #: D-0548-2023

Product: BusPIRone Hydrochloride Tablets USP, 7.5 mg

Variants: 7.5 mg, Tablet, 30-count bottle

Lot Numbers:

F117312201 (Exp. 06/30/2024)

NDC:

51655-511-52

Recall #: D-0549-2023

Product: Doxazosin Tablets, USP, 4mg

Variants: 4mg, Tablet, 30-count bottle

Lot Numbers:

F107752201 (Exp. 05/31/2024)

NDC:

51655-109-52

Recall #: D-0550-2023

Product: Glimepiride Tablets, USP 2mg

Variants: 2mg, Tablet, 30-count bottle, 90-count bottle

Lot Numbers:

F106252201 (Exp. 09/30/2024)

F106252301 (Exp. 5/31/2025)

F106252303 (Exp. 5/31/2025)

F106252304 (Exp. 07/31/2025)

F106252302 (Exp. 07/31/2025)

NDC:

51655-383-52

51655-383-26

Recall #: D-0551-2023

Product: Tadalafil Tablets, USP 20 mg

Variants: 20 mg, Tablet, 6-count bottle, 15-count bottle

Lot Numbers:

F113892002 (Exp. 08/31/2023)

F113892201 (Exp. 11/30/2023)

F113892001 (Exp. 08/31/2023)

F113892202 (Exp. 11/30/2023)

F113892203 (Exp. 12/31/2023)

NDC:

51655-473-87

51655-473-54

Recall #: D-0553-2023

Product: Tadalafil Tablets, USP 5 mg

Variants: 5 mg, Tablet, 30-count bottle

Lot Numbers:

F114302001 (Exp. 05/31/2023)

NDC:

51655-487-52

Recall #: D-0554-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91944

Status: Active

Manufacturer: Northwind Pharmaceuticals LLC

Sold By: Retail Pharmacies

Manufactured In: United States

Units Affected: 7 products (99 bottles; 6 bottles; 33 bottles; a) 230 bottles; b) 22 bottles; a) 198 bottles; b) 22 bottles; a)164 bottles; b) 198 bottles; 23 bottles)

Distributed To: Nationwide