Northwind Pharmaceuticals Atorvastatin Calcium Tablets Recall

Why it was recalled

CGMP Deviations

Product description

Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52

Lot numbers, UPCs & expiration codes

Lot # F117192201, Exp. Date 4/30/2023

Where it was sold

Nationwide with the United States

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0548-2023
Classification: Class II
Status: Ongoing
Recall initiated: Mar 16, 2023
FDA report date: May 3, 2023
Quantity: 99 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Northwind Pharmaceuticals LLC

Original FDA data

Every field from FDA enforcement report D-0548-2023, exactly as published.

Show all FDA fields

City: Indianapolis
State: IN
Status: Ongoing
Country: United States
Event ID: 91944
Address: 4838 Fletcher Ave Ste 1000
Code information: Lot # F117192201, Exp. Date 4/30/2023
Postal code: 46203-1642
Report date: May 3, 2023
Product type: Drugs
Recall number: D-0548-2023
Classification: Class II
Recalling firm: Northwind Pharmaceuticals LLC
Product quantity: 99 bottles
Reason for recall: CGMP Deviations
Voluntary / mandated: Voluntary: Firm initiated
Product description: Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52
Distribution pattern: Nationwide with the United States
Recall initiation date: Mar 16, 2023
Initial firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date: Apr 26, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0548-2023, published May 3, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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