Kroger Specialty Pharmacy Recalls Pulmicort Respules Due to Processing Controls
Kroger Specialty Pharmacy is recalling Pulmicort Respules 0.5 mg/2mL due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.
What this means for you
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 recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses or injuries, placing this in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04. The recall was initiated because of a lack of processing controls. The agency has classified this recall as Class II.
The affected product was dispensed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The recall covers 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 instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Inhalation Solution
- 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
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.
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