METOPROLOL TARTRATE

Generic: METOPROLOL TARTRATE

Aurobindo Pharma LimitedManufacturer
ORALRoute
METOPROLOL TARTRATEActive Substance
2007-09-11Original Approval

METOPROLOL TARTRATE is FDA application ANDA077739, sponsored by AUROBINDO PHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2023-01-05
Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Labor

Failed Dissolution Specification

Class II2023-01-05
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Labora

Failed Dissolution Specification

Class II2013-12-13
Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratori

Failed Dissolution Specification; 12-Month stability interval.

Class II2021-03-15
Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured f

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Class II2021-09-09
Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princ

Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tab

Class II2014-05-23
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. R

Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.

Class III2018-10-15
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured

Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impact

Class II2024-05-06
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manu

Presence of Foreign Substance: metal in tablet

Class II2021-12-20
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories

Failed Dissolution Specifications

Class II2018-04-23
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's La

Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found i

Top Reported Reactions

1
FATIGUE
20,967 reports
2
DYSPNOEA
18,013 reports
3
DIARRHOEA
17,787 reports
4
NAUSEA
17,310 reports
5
DRUG INEFFECTIVE
15,766 reports
6
DIZZINESS
14,920 reports
7
OFF LABEL USE
13,159 reports
8
DEATH
12,503 reports
9
ASTHENIA
11,852 reports
10
HEADACHE
11,753 reports