The Recall Desk
SevereFDA (Drugs)·D-0735-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Albuterol Inhalation Solution Due to Processing Controls

Kroger Specialty Pharmacy is recalling Albuterol 0.083% Inhalation Solution due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization reports are rated as Severe (4).

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Albuterol 0.083% Inhalation Solution, a prescription medication used for respiratory conditions. The recall was initiated due to a lack of processing controls. The affected product is identified by NDC 76204-0200-60 and is a 30-day supply.

The recall covers 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.

Consumers who have this medication should contact their healthcare provider or pharmacist for guidance on how to proceed. The FDA has classified this recall as Class II, indicating a temporary or medically reversible adverse health consequence.

The recalled product

Product
Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30

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 →