The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0752-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Bethkis Ampules Due to Processing Control Issues

Kroger Specialty Pharmacy is recalling Bethkis 300 mg/4 mL ampules due to a lack of processing controls. The affected product was distributed in five states.

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, and the source text does not report any illnesses, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Bethkis 300 mg/4 mL Ampule #56 (NDC 10122-0820-56), a 56-day supply. The recall was initiated because of a lack of processing controls.

The affected product was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The recall includes all lots remaining within expiry that were dispensed between December 1, 2017, and February 12, 2018.

Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions on how to proceed.

The recalled product

Product
Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply
Manufacturer
Kroger Specialty Pharmacy, Inc.
Category
Drug — Injectable 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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