Buspirone Hydrochloride Tablet
FDA Recall NDC 51655-511
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Buspirone Hydrochloride (NDC 51655-511). A significant event, classified as Class II, was initiated on Mar 16, 2023 by Northwind Health Company, Llc. The reported reason for this action was: "CGMP Deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations
Mar 16, 2023
May 03, 2023
6 bottles
Recall Profile & Regulatory Data
Event ID
91944
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Northwind Pharmaceuticals LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide with the United States
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
Batch or Lot Expiration Information
Lot# : F117312201, Exp. Date 06/30/2024
Affected Packages Involved in this Recall
51655-511-52Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
