Recalls / Class II
Class IID-0553-2023
Product
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
- Brand name
- Tadalafil
- Generic name
- Tadalafil
- Active ingredient
- Tadalafil
- Route
- Oral
- NDC
- 51655-473
- FDA application
- ANDA209167
- Affected lot / code info
- a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023; F113892202, Exp. Date 11/30/2023; F113892203, Exp. Date 12/31/2023
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
- a)164 bottles; b) 198 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-0553-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.