The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-012-2014·Announced 2013-11-27

Hospira Recalls Metoclopramide Injection Due to Glass Particulate Matter

Hospira Inc. is recalling 251,400 vials of Metoclopramide Injection because glass spicules were found during a site inspection.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (glass spicules) in an injectable drug, which poses a significant risk of injury upon administration.

Plain-English summary

Hospira Inc. is recalling 251,400 vials of Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial. The product is identified by NDC 0409-3414-01 and Lot # 28-104-DK*, with an expiration date of 10/01/2014. The recall was initiated due to the presence of particulate matter, specifically glass spicules (glass strands), which were identified during a site inspection of the vials.

The affected product was distributed nationwide and in Puerto Rico. This is a prescription-only sterile injection intended for intramuscular or intravenous use. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should stop using the affected vials immediately. Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or healthcare provider for disposal or replacement.

The recalled product

Product
METOCLOPRAMIDE (METOCLOPRAMIDE)
Brand
METOCLOPRAMIDE
Manufacturer
Hospira Inc.
Category
Drug — Injectable Prescription Drug
Hazard
Affected units
251,400

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 28-104-DK*
  • Exp 10/01/2014 (* lot number may be proceeded with an 01)

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · METOCLOPRAMIDE

Same manufacturer · Hospira Inc.

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Same hazard · glass particulate

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