The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0797-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Tasigna Capsules Due to Processing Controls

Kroger Specialty Pharmacy is recalling Tasigna Capsules 150 mg due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.

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 source text identifies this as an FDA Class II recall. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when specific injury reports are not explicitly detailed but the classification itself warrants a higher severity level than Moderate.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Tasigna Capsules 150 mg (NDC 00078-0592-87, 28-day supply) because of a lack of processing controls. This FDA Class II recall involves all lots remaining within expiry that were dispensed between December 1, 2017, and February 12, 2018.

The affected products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The recall is classified as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. No specific illness or injury reports are mentioned in the source text.

The recalled product

Product
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Manufacturer
Kroger Specialty Pharmacy, Inc.
Category
Drug — Prescription Medication
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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