Kroger Specialty Pharmacy Recalls Glatiramer Acetate Due to Processing Controls
Kroger Specialty Pharmacy is recalling Glatiramer Acetate 40 mg/mL due to a lack of processing controls. The affected product was dispensed in five states.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe).
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Glatiramer Acetate 40 mg/mL (NDC 00378-6961-12, 28 days supply) because of a lack of processing controls. The recall covers all lots remaining within expiry that were dispensed between December 1, 2017, and February 12, 2018.
The affected product was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The U.S. Food and Drug Administration 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 pharmacist for instructions on how to dispose of the medication or obtain a replacement. Do not use the recalled product until further notice.
The recalled product
- Product
- Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Prescription 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.
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 controls
See all →- HighCompounded tirzepatide 8.8 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded tirzepatide 11.24 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded semaglutide 0.22 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded semaglutide 0.44 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded tirzepatide 4.4 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13