Kroger Specialty Pharmacy Recalls Copaxone 40 mg Injections Due to Processing Controls
Kroger Specialty Pharmacy is recalling Copaxone 40 mg injections due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.
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 classified as FDA Class II, which typically corresponds to a High severity score (3) when no specific hospitalizations or severe injuries are reported in the source text.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Copaxone 40 mg Injection (12) NDC 68546-0325-12, a 28-day supply. The recall was initiated due to a lack of processing controls.
The affected products were dispensed between December 1, 2017, and February 12, 2018. The recall covers all lots remaining within their expiry date that were dispensed during this period. The products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
Consumers who have this product should contact their healthcare provider or Kroger Specialty Pharmacy for further instructions. 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 40 mg Injection (12) NDC 68546-0325-12 28 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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