Class II · Moderate risk
Metoclopramide Tablets
Presence of foreign tablets/capsules.
Metoclopramide Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01
Affected NDC
0409-3414-01
Compare with the code on your package — it is the most precise check available.
Drug: Metoclopramide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Metoclopramide NDC 00409-3414 |
HYDROCHLORIDE 5 mg/mL | Injection, Solution Intramuscular|intravenous |
Hospira, Inc. | Rx |
- Recalling firm
- Hospira Inc.
- NDC code
- 0409-3414-01
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-012-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Metoclopramide recalls
See all
Class II · Moderate risk
Metoclopramide Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Metoclopramide Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Metoclopramide Injection USP
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Class II · Moderate risk
Metoclopramide Injection USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Other recalls by Hospira Inc.
All 2013 recalls
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
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