Kroger Recalls Pulmozyme Inhalation Solution Due to Lack of Processing Controls
Kroger Specialty Pharmacy is recalling one lot of Pulmozyme inhalation solution because it lacks processing controls, which may affect product quality.
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 FDA Class II due to a lack of processing controls, which poses a risk of harm where injury has not yet been reported. This aligns with the High severity criterion for risk-of-harm products without reported injuries.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is voluntarily recalling Pulmozyme 1 mg/mL Inhalation Solution (NDC 50242-0100-40). The recall affects a 30-day supply of the medication distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
The reason for the recall is a lack of processing controls. This manufacturing issue could potentially impact the quality or safety of the drug product.
Consumers who have this specific product should contact Kroger Specialty Pharmacy for further instructions. The company has not reported any adverse events or illnesses related to this recall at this time.
The recalled product
- Product
- Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Inhalation Solution
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.
See all 67 products in this recall →Related recalls
Same manufacturer · Kroger Specialty Pharmacy, Inc.
See all →- HighKroger Recalls Botox Due to Lack of Processing Controls
FDA (Drugs) · 2018-05-16
- HighKroger Recalls Capecitabine Tablets Due to Lack of Processing Controls
FDA (Drugs) · 2018-05-16
- ModerateKroger Specialty Pharmacy Recalls Cimzia 200 mg/mL PFS Kits
FDA (Drugs) · 2018-05-16
- HighKroger Recalls Lupron Depot Due to Lack of Processing Controls
FDA (Drugs) · 2018-05-16
- ModerateKroger Specialty Pharmacy Recalls Cyclophosphamide Capsules Due to Processing Controls
FDA (Drugs) · 2018-05-16
Same hazard · processing control failure
See all →- ModerateB-Complex Injection Recalled Due to Lack of Processing Controls
FDA (Drugs) · 2021-12-22
- SevereRandall Ultimate 4-Bean Mix Recalled for Lack of Temperature Indicators
FDA (Food) · 2021-08-04
- HighRandall Garbanzo Beans Recall: Defective Temperature Monitoring Devices
FDA (Food) · 2021-08-04
- HighKroger Recalls Sprycel Tablets Due to Lack of Processing Controls
FDA (Drugs) · 2018-05-16
- HighKroger Recalls Revlimid Due to Lack of Processing Controls
FDA (Drugs) · 2018-05-16
Similar recalls
- SeverePharmakon Recalls Midazolam HCl Bags Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SevereKey Pharmacy Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns
FDA (Drugs) · 2017-05-24
- ModeratePharmasol Lung Cleaner Saline Eucalyptus Inhaler Recall
FDA (Drugs) · 2022-03-02
- ModerateWise Pharmacy Recalls Alprostadil Injectable Due to Lack of Processing Controls
FDA (Drugs) · 2019-08-07
- SevereRedline Pharmacy Recalls Morphine Sulfate Due to Processing Control Deficiencies
FDA (Drugs) · 2020-03-18
- SevereRedline Pharmacy Recalls Vancomycin Injectable Due to Processing Control Deficiencies
FDA (Drugs) · 2020-03-18