The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0789-2018·Announced 2018-05-16

Kroger Recalls Imatinib Mesylate Tablets Due to Lack of Processing Controls

Kroger Specialty Pharmacy is recalling one lot of Imatinib Mesylate 400 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 FDA classified this as a Class II recall due to a lack of processing controls, which presents a risk of harm where injury has not yet been reported. Per the rubric, this aligns with the High severity criteria for risk-of-harm products without reported illness.

Plain-English summary

Kroger Specialty Pharmacy, Inc. has initiated a voluntary recall of Imatinib Mesylate Tablet 400 mg (NDC 60505-2901-03). The recall affects all lots remaining within their expiry date that were dispensed between December 1, 2017, and February 12, 2018. The product was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.

The U.S. Food and Drug Administration (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 quality or safety of the medication, although no illnesses or injuries have been reported at this time.

Consumers who may have received this product should contact Kroger Specialty Pharmacy immediately to return the tablets or obtain a replacement. Healthcare providers and patients are advised to check lot numbers against the recall information provided by the FDA.

The recalled product

Product
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
Manufacturer
Kroger Specialty Pharmacy, Inc.
Category
Drug — Imatinib Mesylate Tablet 400 mg
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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