Kroger Specialty Pharmacy Recalls Cayston Inhalation Solution Due to Processing Controls
Kroger Specialty Pharmacy is recalling Cayston 75 mg inhalation solution due to lack of processing controls. The 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 3/5 (High).
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. Per the rubric, FDA Class II recalls without specific reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Cayston 75 mg Inhalation Solution, Single Dose Vial (NDC 61958-0901-01), 56-day supply. The recall is being conducted due to a lack of processing controls.
The affected lots are those remaining within expiry 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 product should contact their healthcare provider or pharmacist for instructions on how to proceed. The FDA has classified this recall as Class II, meaning it may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply
- 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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