The Recall Desk
ModerateFDA (Drugs)·D-0757-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Sodium Chloride Inhalation Solution Due to Processing Controls

Kroger Specialty Pharmacy is recalling Sodium Chloride 3% Inhalation Solution due to a lack of processing controls. The product was distributed in five states.

What this means for you

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 agency classified this as an FDA Class II recall. The source text does not report any illnesses, injuries, or specific contamination, indicating a theoretical or low-risk hazard consistent with a moderate severity score.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Sodium Chloride 3% Inhalation Solution, 4 mL NEP #30, NDC 00487-9003-60. The recall is being conducted due to a lack of processing controls. The affected product is a 30-day supply.

The recalled 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 stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply.

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 →