FDA Recall D-0549-2023
Northwind Pharmaceuticals LLC · Indianapolis, IN
Class II Ongoing 1155 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52
Reason for recall
CGMP Deviations
Recall record
- Recall number
D-0549-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide with the United States
- Recall initiated
- 2023-03-16
- Classified by FDA Center
- 2023-04-26
- FDA published
- 2023-05-03
- Recalling firm
- Northwind Pharmaceuticals LLC
- Firm location
- Indianapolis, IN
Drug identification
- Brand name(s)
- BUSPIRONE HYDROCHLORIDE
- Generic name(s)
- BUSPIRONE HYDROCHLORIDE
- Manufacturer(s)
- Northwind Health Company, LLC
- NDC(s)
51655-511- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.