Kroger Specialty Pharmacy Recalls Avonex PFS Kits Due to Processing Controls
Kroger Specialty Pharmacy is recalling Avonex 30 mcg/0.5 mL PFS Kits due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.
What this means for you
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 FDA classified this as a Class II recall. Per the rubric, a Class II recall without specific reports of hospitalization or significant injury falls under the 'High' severity category, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Avonex 30 mcg/0.5 mL PFS Kits (NDC 59627-0222-05, 28 days supply) because of a lack of processing controls. The recall covers all lots remaining within their expiration date that were dispensed between December 1, 2017, and February 12, 2018.
The affected products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. 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.
Consumers who have this product should contact their healthcare provider or Kroger Specialty Pharmacy for instructions on how to return the medication or obtain a replacement. Do not use the recalled product until further notice.
The recalled product
- Product
- Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Injectable Medication
- 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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