The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0793-2018·Announced 2018-05-16

Kroger Recalls Ondansetron Tablets Due to Lack of Processing Controls

Kroger Specialty Pharmacy is recalling one lot of Ondansetron 8 mg tablets because the product lacked required processing controls.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is FDA Class II due to a lack of processing controls, which poses a risk of harm where injury has not yet been reported. According to the rubric, this falls under 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is voluntarily recalling one lot of Ondansetron 8 mg tablets (NDC 57237-0076-30) distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The recall covers a 28-day supply dispensed between December 1, 2017, and February 12, 2018.

The FDA classified this recall as Class II. The reason for the recall is a lack of processing controls during manufacturing. This defect could potentially affect the safety or efficacy of the medication, although no illnesses have been reported.

Consumers who may have received this product should contact Kroger Specialty Pharmacy to return the medication. Healthcare providers and patients are advised to check lot numbers against the recall notice.

The recalled product

Product
Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply
Manufacturer
Kroger Specialty Pharmacy, Inc.
Category
Drug — Ondansetron 8 mg tablet
Hazard

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 (1)

  • All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 67 recalled by Kroger Specialty Pharmacy, 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 67 products in this recall →

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