METOCLOPRAMIDE
Generic: METOCLOPRAMIDE
HospiraManufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
METOCLOPRAMIDE HYDROCHLORIDEActive Substance
1991-01-17Original Approval
METOCLOPRAMIDE is FDA application ANDA073118, sponsored by HOSPIRA. 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 II2025-05-23
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Presence of foreign tablets/capsules.
Class II2021-02-10
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL SingleLack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance le
Class II2021-04-26
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. IrvinLack of Assurance of Sterility
Class II2013-09-24
Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were
Class II2021-02-15
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva PharmaceuticaChemical contamination; Unknown brown residue adhering to the inside of one vial.
Class II2021-07-29
Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine,Lack of Assurance of Sterility
Top Reported Reactions
1
TARDIVE DYSKINESIA
15,392 reports
2
EXTRAPYRAMIDAL DISORDER
12,516 reports
3
NERVOUS SYSTEM DISORDER
7,403 reports
4
DYSTONIA
6,995 reports
5
PAIN
5,034 reports
6
NAUSEA
4,777 reports
7
ECONOMIC PROBLEM
3,807 reports
8
VOMITING
3,679 reports
9
ANXIETY
3,335 reports
10
DIARRHOEA
3,220 reports