Nortriptyline Hydrochloride Capsule
FDA Recall NDC 51672-4002
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 Nortriptyline Hydrochloride (NDC 51672-4002). A significant event, classified as Class II, was initiated on Jan 08, 2021 by Taro Pharmaceuticals U.s.a., Inc.. The reported reason for this action was: "CGMP deviations."
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.
Jan 08, 2021
Feb 10, 2021
44,256 bottles
Recall Profile & Regulatory Data
Event ID
87152
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 07, 2023
Product Description
Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1
Batch or Lot Expiration Information
Lot# AC05096, AC05098, and AC05099; Exp 10/31/2022
Affected Packages Involved in this Recall
51672-4001-6Product
51672-4001-5Product
51672-4001-1Product
51672-4001-2Product
51672-4002-6Product
51672-4002-4Product
51672-4002-5Product
51672-4002-1Product
51672-4002-2Product
51672-4003-6Product
51672-4003-5Product
51672-4003-1Product
51672-4003-2Product
51672-4004-6Product
51672-4004-5Product
51672-4004-1Product
51672-4004-2Product
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.
