Kroger Specialty Pharmacy Recalls Enbrel PFS Due to Processing Control Issues
Kroger Specialty Pharmacy is recalling Enbrel PFS 50 mg/mL injections due to a lack of processing controls. The affected lots were 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, and the source text does not report any illnesses, injuries, or specific contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Enbrel PFS 50 mg/mL Inj #4 (NDC 58406-0435-04), a 28-day supply. The recall was initiated because of a lack of processing controls.
The affected product was dispensed to patients in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The recall covers all lots remaining within their expiry date that were dispensed between December 1, 2017, and February 12, 2018.
Consumers who have this medication should contact their healthcare provider or pharmacist for further instructions on how to proceed.
The recalled product
- Product
- Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 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.
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