Status
Ongoing
Drug Enforcement D-0553-2023
CGMP Deviations
Classification
Class II
Report Date
May 3, 2023
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- a)164 bottles; b) 198 bottles
- Reason for recall
- CGMP Deviations
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide with the United States
Location & Firm
- Recalling firm
- Northwind Pharmaceuticals LLC
- Address
-
4838 Fletcher Ave Ste 1000, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0553-2023
- Event ID
- 91944
- Recall initiation date
- March 16, 2023
- Center classification date
- April 26, 2023
- 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
- More code info
- —