Kroger Specialty Pharmacy Recalls Cosentyx Due to Processing Control Issues
Kroger Specialty Pharmacy is recalling Cosentyx 150 mg/mL prefilled syringes due to a lack of processing controls. The recall affects specific lots dispensed in five states.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Cosentyx 150 mg/mL PFS 300 mg Dose (NDC 00078-0639-98, 28 days supply) because of a lack of processing controls. The agency has classified this recall as Class II.
The recall covers all lots remaining within their expiry date that were dispensed between December 1, 2017, and February 12, 2018. These products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Biologic
- 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.
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
See all →- ModerateTestosterone Gel Recalled by Florida Pharmacy for Lack of Processing Control
FDA (Drugs) · 2020-04-22
- ModerateParegoric Alternate Elixir Recalled for Lack of Processing Control
FDA (Drugs) · 2020-04-22
- ModerateHydrocortisone Cream Recalled for Lack of Processing Control
FDA (Drugs) · 2020-04-22
- ModerateErgotamine Tartrate and Caffeine Suppositories Recalled for Processing Control Issues
FDA (Drugs) · 2020-04-22
- SevereBi-Est Cream Recalled for Lack of Processing Control
FDA (Drugs) · 2020-04-22