Recalls / Class II
Class IID-0548-2023
Product
Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52
- Brand name
- Atorvastatin Calcium
- Generic name
- Atorvastatin Calcium
- Active ingredient
- Atorvastatin Calcium Trihydrate
- Route
- Oral
- NDC
- 51655-946
- FDA application
- ANDA207687
- Affected lot / code info
- Lot # F117192201, Exp. Date 4/30/2023
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Northwind Pharmaceuticals LLC
- Manufacturer
- Northwind Health Company, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 4838 Fletcher Ave Ste 1000, N/A, Indianapolis, Indiana 46203-1642
Distribution
- Quantity
- 99 bottles
- Distribution pattern
- Nationwide with the United States
Timeline
- Recall initiated
- 2023-03-16
- FDA classified
- 2023-04-26
- Posted by FDA
- 2023-05-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0548-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.