The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0548-2023·Announced 2023-05-03

Atorvastatin Calcium Tablets Recalled for Manufacturing Quality Violations

Northwind Pharmaceuticals is recalling 99 bottles of Atorvastatin Calcium 10 mg tablets nationally due to manufacturing process deviations identified in March 2023.

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 voluntary recall for manufacturing process deviations without reported illnesses or injuries. CGMP violations in the absence of confirmed harm represent precautionary recalls, which the rubric identifies as Moderate (score 2).

Plain-English summary

Northwind Pharmaceuticals LLC is voluntarily recalling Atorvastatin Calcium Tablets, USP 10 mg in 30-count bottles due to Current Good Manufacturing Practice (CGMP) deviations. The affected product is identified as NDC 51655-946-52, Lot # F117192201, with an expiration date of April 30, 2023. A total of 99 bottles were distributed nationwide across the United States.

The company initiated the recall on March 16, 2023. The FDA classified the recall as Class II. Northwind notified customers through email, fax, letter, press release, telephone, and in-person visits.

Consumers who have this medication should contact their pharmacist or healthcare provider about the recall. Patients should not stop taking atorvastatin without consulting their doctor, as the medication is essential for managing cholesterol levels. A healthcare provider can verify whether a patient's supply is affected and determine appropriate next steps.

The recalled product

Product
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand
ATORVASTATIN CALCIUM
Manufacturer
Northwind Pharmaceuticals LLC
Category
Drug
Hazard
Affected units
99

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 # F117192201
  • Exp. Date 4/30/2023

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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