Kroger Specialty Pharmacy Recalls Copaxone 20 mg Injection Due to Processing Controls
Kroger Specialty Pharmacy is recalling Copaxone 20 mg Injection PFS due to a lack of processing controls. The affected lots were dispensed between December 2017 and February 2018 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 2/5 (Moderate).
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 FDA classified this as a Class II recall, and the source text does not report any illnesses, injuries, or hospitalizations, aligning with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30, a 30-day supply. The recall was initiated because of 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 guidance on what to do next. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply.
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Injection
- 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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