Kroger Specialty Pharmacy Recalls Zarxio Due to Processing Control Issues
Kroger Specialty Pharmacy is recalling Zarxio 300 mcg/0.5 mL PFS due to lack of processing controls. The recall affects specific lots dispensed between December 2017 and February 2018.
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 recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is described as a lack of processing controls without specific pathogen or injury details, fitting the Moderate category for a precautionary or low-risk contamination scenario.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply. The recall is being conducted due to a lack of processing controls. The FDA 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. The source text does not specify the total number of units affected or report any specific illnesses or injuries.
Consumers who have this product should contact their healthcare provider or pharmacist for instructions on how to proceed. The source text does not provide specific consumer action steps beyond the general recall notice.
The recalled product
- Product
- Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Injectable Medication
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 defect
See all →- HighEstriol Vaginal Cream Recalled for Insanitary Manufacturing Conditions
FDA (Drugs) · 2022-07-13