PANTOPRAZOLE SODIUM

Generic: PANTOPRAZOLE SODIUM

CivicaManufacturer
INTRAVENOUSRoute
PANTOPRAZOLE SODIUMActive Substance
2017-06-30Original Approval

PANTOPRAZOLE SODIUM is FDA application NDA209463, sponsored by HIKMA. 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 II2026-08-06
Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAX

CGMP Deviations

Class III2021-02-05
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. C

Failed Impurity/Degradation Specifications

Class III2016-12-16
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC

Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

Class I2017-12-04
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Phar

Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) con

Class II2022-04-11
Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharma

CGMP deviations: tablets cracking

Class II2023-09-05
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials

Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

Class II2023-03-14
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceutic

CGMP Deviations: Discoloration

Class II2022-07-25
Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet

Discoloration

Class II2026-03-26
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceu

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than norma

Class II2021-03-15
Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urba

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
FATIGUE
20,776 reports
2
OFF LABEL USE
18,627 reports
3
NAUSEA
17,860 reports
4
DIARRHOEA
17,557 reports
5
DYSPNOEA
17,288 reports
6
DRUG INEFFECTIVE
17,210 reports
7
PAIN
15,532 reports
8
HEADACHE
13,326 reports
9
VOMITING
12,781 reports
10
ARTHRALGIA
12,261 reports