Metoprolol Injection
FDA Recall NDC 36000-033
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 Metoprolol (NDC 36000-033). A significant event, classified as Class III, was initiated on Oct 15, 2018 by Baxter Healthcare Corporation. The reported reason for this action was: "Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots."
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 III Terminated
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Oct 15, 2018
Nov 14, 2018
402,165 vials
Recall Profile & Regulatory Data
Event ID
81353
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed nationwide in the USA and Puerto Rico
Termination Date
Aug 12, 2022
Product Description
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10
Batch or Lot Expiration Information
Lot# S: A061267, A061273,EXP 10/2018; A061392, A061395, A061398, A061403, A061407, EXP 11/2018; A0A0070, A0A0073, A0A0079, A0A0081, A0A0083, EXP 12/2018; A0A0119, A0A0124, A0A0125, A0A0133, A0A0141, A0A0145, A0A0152, EXP 1/2019; A0A0247, A0A0252, A0A0253, A0A0292, A0A0293, EXP 2/2019; A0A0361, A0A0367, A0A0390, EXP 3/2019; A0A0438, A0A0445, A0A0453, A0A0459, EXP 4/2019; A0A0547, A0A0551, A0A0554, A0A0630, A0A0631, A0A0637, A0A0638, EXP 5/2019; A0A0777, EXP 7/2019; A0A0915, A0A0919, A0A0924, A0A0930, EXP 8/2019; A0A1094, A0A1097, A0A1110, EXP 11/2019
Affected Packages Involved in this Recall
36000-033-10Product
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.
