Nizatidine Solution
FDA Recall NDC 60846-301
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 Nizatidine (NDC 60846-301). A significant event, classified as Class II, was initiated on Apr 15, 2020 by Amneal Pharmaceuticals Llc. The reported reason for this action was: "CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Apr 15, 2020
May 06, 2020
11258 bottles
Recall Profile & Regulatory Data
Event ID
85386
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 08, 2021
Product Description
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
Batch or Lot Expiration Information
Lot# 06598004A 04/2020 06599001A 12/2020 06599002A 12/2020
Affected Packages Involved in this Recall
60846-301-15Product
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.
