Status
Ongoing
Drug Enforcement D-0549-2023
CGMP Deviations
Classification
Class II
Report Date
May 3, 2023
Termination Date
—
Product Information
- Product description
- BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52
- Product quantity
- 6 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-0549-2023
- Event ID
- 91944
- Recall initiation date
- March 16, 2023
- Center classification date
- April 26, 2023
- Code info
- Lot#: F117312201, Exp. Date 06/30/2024
- More code info
- —