The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1497-2016·Announced 2016-09-14

Teva Recalls Ondansetron Injection Vials Due to Manufacturing Deviations

Teva North America is recalling 13,223 vials of Ondansetron Injection USP due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is based on manufacturing deviations (CGMP) without confirmed adverse health consequences, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Teva North America is voluntarily recalling 13,223 vials of Ondansetron Injection USP 40 mg/20 mL (2 mg/mL). The product is a prescription-only medication manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC. The recall involves specific lots: 2930614, 2940614, and 2950614, all within their expiry dates.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed nationwide and in Puerto Rico. The recall was initiated on June 17, 2016, and was terminated on February 7, 2017.

Healthcare providers and patients should check their inventory for the specific NDC numbers 0703-7226-01 and 0703-72263-03 and the listed lot numbers. If found, the product should be quarantined and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
Manufacturer
Teva North America
Category
Drug — Injection
Hazard
Affected units
13,223

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 (3)

  • All Lots Within Expiry Lot # 2930614
  • 2940614
  • 2950614

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 4 recalled by Teva North America 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 4 products in this recall →

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